RegWardenFDA facility compliance records
Facility

BOSTON SCIENTIFIC CORPORATION

187 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 11 recalls; 2014: 10 recalls; 2015: 14 recalls; 2016: 7 recalls, 1 inspections; 2017: 14 recalls; 2018: 8 recalls; 2019: 11 recalls; 2020: 21 recalls; 2021: 13 recalls; 2022: 11 recalls; 2023: 10 recalls; 2024: 18 recalls; 2025: 16 recalls; 2026: 21 recalls2’1211’1310’1414’158’1614’178’1811’1921’2013’2111’2210’2318’2416’2521’26
  • Recalls (187)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

202621 records
  • Class IOngoing2026-08-24
    Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
  • Class IIOngoing2026-08-06
    There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
  • Class IIOngoing2026-07-22
    A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
  • Class IIOngoing2026-07-14
    Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
  • Class IOngoing2026-07-09
    Potential for arterial sheath tip separation or partial tip separation during use.
  • Class IIOngoing2026-06-30
    Potential for breach in sterile barrier of device packaging.
  • Class IIOngoing2026-06-30
    Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to asp…
  • Class IIOngoing2026-06-19
    Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that wer…
  • Class IOngoing2026-06-17
    Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
  • Class IIOngoing2026-06-11
    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and…
  • Class IIOngoing2026-06-11
    Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
  • Class IIOngoing2026-06-11
    Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
  • Class IIOngoing2026-05-21
    Potential sterile breach of the pouches in which devices are packaged.
  • Class IIOngoing2026-05-12
    Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
  • Class IICompleted2026-05-11
    There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
  • Class IIOngoing2026-04-29
    Sterile anchors my lack sterility assurance.
  • Class IIOngoing2026-04-29
    Reusable electrodes may not meet expected performance levels.
  • Class IIOngoing2026-04-22
    Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
  • Class IIOngoing2026-03-30
    For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITU…
  • Class IOngoing2026-03-19
    Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) d…
  • Class IIOngoing2026-02-10
    Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manu…
202516 records
  • Class IOngoing2025-12-19
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in case…
  • Class IIOngoing2025-12-03
    Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An inter…
  • Class IIOngoing2025-09-11
    The potential for devices to experience inflation and/or deflation performance issues or difficulties.
  • Class IIOngoing2025-08-28
    The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
  • Class IOngoing2025-08-20
    Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) …
  • Class IIOngoing2025-08-18
    Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
  • Class IIOngoing2025-08-05
    The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Device…
  • Class IOngoing2025-07-29
    Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atr…
  • Class IOngoing2025-07-24
    Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
  • Class IIOngoing2025-07-08
    Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedance…
  • Class IIOngoing2025-07-08
    Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
  • Class IOngoing2025-07-07
    Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful sten…
  • Class IIOngoing2025-06-25
    The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
  • Class IIOngoing2025-06-10
    Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variab…
  • Class IIOngoing2025-06-06
    As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
  • Class IIOngoing2025-03-24
    Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation …
202418 records
  • Class IIOngoing2024-12-20
    Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
  • Class IOngoing2024-12-12
    A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
  • Class IIOngoing2024-10-28
    Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
  • Class IOngoing2024-10-10
    Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
  • Class IIOngoing2024-09-06
    Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
  • Class IIOngoing2024-09-05
    Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Bost…
  • Class IIOngoing2024-08-01
    WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
  • Class IIOngoing2024-07-18
    There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
  • Class IIOngoing2024-07-17
    Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. …
  • Class IIOngoing2024-06-27
    Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
  • Class IIOngoing2024-06-12
    Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
  • Class IIOngoing2024-04-18
    Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of mo…
  • Class IOngoing2024-03-21
    An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
  • Class IIOngoing2024-03-05
    Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
  • Class IIOngoing2024-02-20
    Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention t…
  • Class IOngoing2024-02-20
    An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is…
  • Class IIOngoing2024-02-20
    Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
  • Class IOngoing2024-02-12
    Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introd…
202310 records
  • Class IIOngoing2023-12-19
    Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue nec…
  • Class IIOngoing2023-11-30
    The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
  • Class IIOngoing2023-09-27
    Poor image quality due to fluid ingress in the lens.
  • Class IIOngoing2023-07-27
    Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
  • Class IIOngoing2023-07-11
    There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
  • Class IIOngoing2023-05-25
    Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
  • Class IIOngoing2023-05-12
    Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragmen…
  • Class IIOngoing2023-04-05
    The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
  • Class IIOngoing2023-02-02
    Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LAT…
  • Class IIOngoing2023-02-02
    Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions…
202211 records
  • Class IIOngoing2022-10-13
    Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
  • Class IIOngoing2022-10-12
    Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
  • Class IIOngoing2022-10-10
    ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE G…
  • Class IIOngoing2022-09-30
    There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
  • Class IIOngoing2022-08-09
    The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
  • Class IIOngoing2022-07-07
    There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
  • Class IIIOngoing2022-05-31
    Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber…
  • Class IIOngoing2022-05-25
    Product may be mislabeled.
  • Class IIOngoing2022-03-08
    Pouch seals may be open, compromising sterility.
  • Class IIOngoing2022-03-03
    Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
  • Class IIOngoing2022-02-24
    Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as t…
202113 records
  • Class IIOngoing2021-12-22
    Sterility of device is compromised due to a sterile barrier breach
  • Class IITerminated2021-11-08
    Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
  • Class IIOngoing2021-10-21
    Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
  • Class IIOngoing2021-07-23
    Potential for leaks and loosening at the patient catheter connection
  • Class IIOngoing2021-06-03
    Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
  • Class IOngoing2021-06-03
    The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent batter…
  • Class IITerminated2021-04-21
    One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
  • Class IIOngoing2021-04-15
    Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
  • Class IOngoing2021-04-12
    The firm has received reports of stent migration after implantation
  • Class IITerminated2021-03-26
    An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
  • Class IIITerminated2021-03-16
    May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
  • Class IITerminated2021-03-05
    The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
  • Class IIOngoing2021-01-19
    Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
202021 records
  • Class IITerminated2020-12-15
    Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
  • Class IIOngoing2020-12-02
    Accelerated battery depletion may result in a need for device replacement earlier than expected.
  • Class ITerminated2020-12-02
    Electrical overstress may lead to device malfunction.
  • Class IITerminated2020-12-01
    The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, …
  • Class IICompleted2020-11-18
    Complaint trend regarding needle shaft gas leaks.
  • Class ITerminated2020-11-17
    Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
  • Class IIOngoing2020-11-16
    Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
  • Class ITerminated2020-11-13
    There is potential for fractures which results in the inability to delivery therapy.
  • Class IIOngoing2020-11-03
    This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the …
  • Class IIOngoing2020-09-24
    The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
  • Class IITerminated2020-09-22
    Incorrectly installed base.
  • Class IITerminated2020-09-22
    There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
  • Class IIOngoing2020-09-16
    RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
  • Class IITerminated2020-08-24
    Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential advers…
  • Class IITerminated2020-08-07
    Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
  • Class IIOngoing2020-07-06
    BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury woul…
  • Class IITerminated2020-06-04
    The needle surface deteriorated due to unexpected electrolysis during procedure.
  • Class IITerminated2020-03-30
    To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
  • Class IIOngoing2020-03-09
    An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
  • Class IITerminated2020-02-12
    Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug A…
  • Class IOngoing2020-02-11
    Potential for tip detachment of Imager II 5F Angiographic Catheters
201911 records
  • Class IITerminated2019-12-17
    A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
  • Class IITerminated2019-11-18
    During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling …
  • Class IITerminated2019-11-08
    Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
  • Class IITerminated2019-10-24
    Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
  • Class IITerminated2019-10-21
    Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
  • Class IICompleted2019-09-18
    Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (U…
  • Class IIOngoing2019-08-21
    Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
  • Class IITerminated2019-07-19
    Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
  • Class IITerminated2019-05-30
    The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
  • Class IITerminated2019-04-24
    The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is e…
  • Class IITerminated2019-04-08
    Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-b…
20188 records
  • Class IITerminated2018-12-26
    The sterile barrier may contain packaging seal defects.
  • Class IITerminated2018-12-19
    A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
  • Class IIIOngoing2018-11-28
    Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
  • Class IITerminated2018-11-01
    Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
  • Class IITerminated2018-09-10
    Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
  • Class IITerminated2018-09-10
    There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
  • Class IIOngoing2018-06-20
    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
  • Class IITerminated2018-02-12
    Potential for Capio sutures to break and /or detach.
201714 records
  • Class IITerminated2017-12-20
    Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
  • Class IITerminated2017-12-12
    Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
  • Class IITerminated2017-12-11
    Potential polymer material degradation.
  • Class IIOngoing2017-12-07
    Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Class IIOngoing2017-11-06
    Stent possibly unable to be fully released from the delivery system.
  • Class IITerminated2017-10-04
    The devices have an incorrect firmware configuration.
  • Class IITerminated2017-09-22
    Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
  • Class IITerminated2017-06-29
    The device can deliver an atypical amount of energy due to memory corruption inside the device.
  • Class IITerminated2017-06-15
    Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
  • Class IITerminated2017-06-01
    Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
  • Class IITerminated2017-05-15
    The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
  • Class IITerminated2017-04-05
    Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREA…
  • Class IITerminated2017-01-31
    Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
  • Class IITerminated2017-01-12
    There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session w…
20167 records
  • Class IITerminated2016-12-15
    A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
  • Class IITerminated2016-12-13
    One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
  • Class IITerminated2016-11-30
    Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
  • Class IITerminated2016-06-15
    Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
  • Class IITerminated2016-03-28
    Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most se…
  • Class ITerminated2016-03-22
    Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/imag…
  • Class IITerminated2016-03-18
    Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
201514 records
  • Class IITerminated2015-12-10
    The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
  • Class IITerminated2015-11-25
    Potential for separation of the proximal handle from the shaft.
  • Class IITerminated2015-11-20
    During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.
  • Class ITerminated2015-11-19
    Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments.
  • Class ITerminated2015-10-09
    Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.
  • Class IITerminated2015-09-17
    Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-c…
  • Class IITerminated2015-09-11
    Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability …
  • Class IITerminated2015-08-25
    Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemosta…
  • Class IITerminated2015-07-31
    AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
  • Class IITerminated2015-06-02
    Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on th…
  • Class IITerminated2015-04-27
    One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
  • Class IITerminated2015-02-25
    Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to ret…
  • Class IITerminated2015-02-25
    Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious …
  • Class ITerminated2015-02-03
    Reports of formation of char adherent to the proximal part of the distal tip electrodes
201410 records
  • Class IITerminated2014-11-20
    Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
  • Class ITerminated2014-11-19
    Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surge…
  • Class IITerminated2014-09-30
    Product is not cleared for use with lasers other than the Auriga XL system
  • Class IITerminated2014-09-17
    Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to…
  • Class IITerminated2014-06-19
    A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries…
  • Class IITerminated2014-05-15
    Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
  • Class IITerminated2014-04-03
    Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
  • Class IITerminated2014-03-03
    The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
  • Class IITerminated2014-02-04
    Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots ma…
  • Class IITerminated2014-01-06
    Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
201311 records
  • Class IITerminated2013-12-18
    Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
  • Class IITerminated2013-11-20
    Sterility of device may be compromised due to lack of pouch seal integrity
  • Class IITerminated2013-11-05
    The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
  • Class IITerminated2013-08-29
    The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
  • Class IITerminated2013-07-31
    Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific…
  • Class IITerminated2013-07-15
    Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manuf…
  • Class IITerminated2013-05-28
    Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
  • Class IIITerminated2013-05-28
    Product labeled with incorrect expiration date.
  • Class IITerminated2013-05-28
    Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box…
  • Class IITerminated2013-04-10
    Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-…
  • Class IITerminated2013-03-01
    An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be u…
20122 records
  • Class IITerminated2012-09-17
    Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
  • Class IITerminated2012-05-16
    Difficulty in extending snare loop from the catheter

FDA inspections (1)

  • NAI2016-01-08
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BOSTON SCIENTIFIC CORPORATION (FEI 3004859241) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004859241-boston-scientific-corporation/

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