RegWardenFDA facility compliance records
Facility

ABIOMED, INC.

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

Activity by year

FDA actions on record by year2011: 1 recalls; 2016: 1 inspections; 2017: 1 inspections; 2019: 2 recalls; 2020: 1 inspections; 2021: 2 recalls; 2023: 9 recalls, 1 inspections, 1 warning letters; 2024: 3 recalls; 2025: 5 recalls, 1 inspections; 2026: 9 recalls1’11’12’13’14’151’161’17’182’191’202’21’2211’233’246’259’26
  • Recalls (31)
  • Inspections (5)
  • Warning letters (1)

Devices registered here (1)

  • Device, Intravascular Catheter Securement
    Product code KMK (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5210

Recalls & enforcement

20269 records
  • Class IOngoing2026-08-12
    The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
  • Class IOngoing2026-06-11
    A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
  • Class IOngoing2026-05-22
    Potential for thrombus formation during prolonged use of the introducer.
  • Class IOngoing2026-05-18
    Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
  • Class IOngoing2026-05-14
    Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
  • Class IOngoing2026-04-20
    A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these …
  • Class IOngoing2026-02-18
    Increased risk of purge leaks with Generation 1 purge cassettes.
  • Class IOngoing2026-02-16
    Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
  • Class IOngoing2026-01-27
    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
20255 records
  • Class IIOngoing2025-12-04
    Device packaged in incorrect outer box carton.
  • Class IOngoing2025-10-01
    Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
  • Class IOngoing2025-09-16
    Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
  • Class IOngoing2025-08-20
    Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
  • Class IOngoing2025-06-23
    A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
20243 records
  • Class IOngoing2024-12-12
    Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PA…
  • Class IIOngoing2024-08-05
    A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include inform…
  • Class IOngoing2024-05-31
    Nine (9) Impella CP pumps failed inspection and were inadvertently released.
20239 records
  • Class IIOngoing2023-12-27
    New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
  • Class IOngoing2023-12-27
    IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
  • Class IIOngoing2023-12-06
    The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric dis…
  • Class IIOngoing2023-11-07
    Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leadin…
  • Class IITerminated2023-10-10
    Pump not detected as connected to controller due to software issue.
  • Class IOngoing2023-06-29
    A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hem…
  • Class IOngoing2023-06-14
    There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic e…
  • Class IIOngoing2023-05-26
    There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and …
  • Class IOngoing2023-04-17
    The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
20212 records
  • Class ITerminated2021-12-14
    The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
  • Class IITerminated2021-03-01
    Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
20192 records
  • Class IITerminated2019-09-04
    This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly cause…
  • Class IIOngoing2019-02-19
    Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliab…
20111 record
  • Class IOngoing2011-01-17
    Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive …

FDA inspections (5)

  • OAI2025-08-05
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2023-04-13
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2020-10-06
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices
  • NAI2017-07-27
    No Action Indicated · Bioresearch Monitoring
  • NAI2016-03-25
    No Action Indicated · Compliance: Devices; Project Evaluation: 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.

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. “ABIOMED, INC. (FEI 1220648) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220648-abiomed-inc/

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