RegWardenFDA facility compliance records
Facility

Datascope Corp.

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2016: 3 recalls; 2017: 4 recalls; 2018: 1 recalls, 1 inspections, 1 warning letters; 2019: 4 recalls; 2020: 1 recalls; 2021: 5 recalls; 2022: 3 recalls; 2023: 15 recalls; 2024: 3 recalls; 2025: 2 recalls; 2026: 2 recalls1’14’153’164’173’184’191’205’213’2215’233’242’252’26
  • Recalls (44)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (1)

  • System, Balloon, Intra-Aortic And Control
    Product code DSP (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3535

Recalls & enforcement

20262 records
  • Class IIIOngoing2026-02-06
    The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain ba…
  • Class IIOngoing2026-01-23
    The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
20252 records
  • Class IIOngoing2025-11-04
    The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
  • Class IIIOngoing2025-10-23
    The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
20243 records
  • Class IIOngoing2024-09-17
    There is discrepant labeling on the inner and outer packaging of the device.
  • Class IOngoing2024-08-08
    Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
  • Class IOngoing2024-08-08
    Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
202315 records
  • Class IOngoing2023-07-31
    Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
  • Class IOngoing2023-07-31
    Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (co…
  • Class IIOngoing2023-07-31
    Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
  • Class IOngoing2023-07-31
    Users were identifying autofill failure conditions on the devices causing pump stops.
  • Class IOngoing2023-07-31
    Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
  • Class IIOngoing2023-06-23
    During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB the…
  • Class IOngoing2023-06-05
    IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
  • Class IOngoing2023-06-05
    An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
  • Class IIIOngoing2023-05-04
    The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
  • Class IIOngoing2023-04-04
    The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
  • Class IIOngoing2023-02-28
    There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction i…
  • Class IIOngoing2023-02-07
    There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hos…
  • Class IOngoing2023-02-07
    An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
  • Class IOngoing2023-02-07
    An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left una…
  • Class IIOngoing2023-02-07
    Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
20223 records
  • Class IOngoing2022-12-19
    The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
  • Class IIOngoing2022-08-05
    Certain lots containing undersized dilator.
  • Class IIOngoing2022-08-05
    The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamic…
20215 records
  • Class IOngoing2021-11-15
    Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
  • Class IOngoing2021-09-21
    A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
  • Class IIOngoing2021-09-08
    The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
  • Class IIOngoing2021-09-08
    The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
  • Class IIIOngoing2021-03-22
    There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
20201 record
20194 records
  • Class IITerminated2019-11-20
    Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
  • Class IITerminated2019-10-03
    One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
  • Class IOngoing2019-06-17
    If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
  • Class IITerminated2019-05-28
    The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
20181 record
  • Class IITerminated2018-02-21
    The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
20174 records
  • Class IITerminated2017-10-19
    The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in E…
  • Class IITerminated2017-07-27
    There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
  • Class IITerminated2017-04-12
    Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the…
  • Class IITerminated2017-02-16
    A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
20163 records
  • Class IITerminated2016-05-13
    It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU fo…
  • Class IITerminated2016-05-09
    Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
  • Class IIITerminated2016-03-11
    There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
20141 record
  • Class IIITerminated2014-08-11
    During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

FDA inspections (1)

  • OAI2018-06-11
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “Datascope Corp. (FEI 1000222374) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000222374-datascope-corp/

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