Impella Heart PumpRecalls & reported problems across all models

We found 34 models of Impella Heart Pump by Abiomed, Inc. in the FDA's device registry (GUDID). Together they are named in 30,421 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2015 and Sep 30, 2026 — classified as 3,817 deaths, 15,140 injuries, 11,464 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (2,416 reports).

46 FDA recall records name at least one of these models by its device identifier, 42 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Impella Heart Pump recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 12, 2026Open, Classified

   The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

   Z-3150-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 12, 2026Open, Classified

   The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

   Z-3149-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Aug 12, 2026Open, Classified

   The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

   Z-3148-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

4. Jun 11, 2026Open, Classified

   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.

   Z-2686-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. Jun 11, 2026Open, Classified

   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.

   Z-2685-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

6. Jun 11, 2026Open, Classified

   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.

   Z-2684-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Jun 11, 2026Open, Classified

   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.

   Z-2683-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jun 11, 2026Open, Classified

   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.

   Z-2682-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

9. Jun 11, 2026Open, Classified

   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.

   Z-2681-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. May 22, 2026Open, Classified

    Potential for thrombus formation during prolonged use of the introducer.

    Z-2601-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. May 22, 2026Open, Classified

    Potential for thrombus formation during prolonged use of the introducer.

    Z-2599-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. May 18, 2026Open, Classified

    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.

    Z-2457-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. May 14, 2026Open, Classified

    Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

    Z-2360-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

14. Apr 20, 2026Open, Classified

    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 updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

    Z-2211-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. Feb 18, 2026Open, Classified

    Increased risk of purge leaks with Generation 1 purge cassettes.

    Z-1589-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

16. Feb 16, 2026Open, Classified

    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.

    Z-1591-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

17. Jan 27, 2026Open, Classified

    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

    Z-1470-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

18. Jan 27, 2026Open, Classified

    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

    Z-1469-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

19. Dec 4, 2025Open, Classified

    Device packaged in incorrect outer box carton.

    Z-1030-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. Oct 1, 2025Open, Classified

    Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

    Z-0069-2026 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗

21. Sep 16, 2025Open, Classified

    Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

    Z-0136-2026 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

22. Aug 20, 2025Open, Classified

    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.

    Z-2568-2025 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

23. Jun 23, 2025Open, Classified

    A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

    Z-2164-2025 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

24. Dec 12, 2024Open, Classified

    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 (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

    Z-0830-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

25. Dec 12, 2024Open, Classified

    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 (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

    Z-0829-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

26. Aug 5, 2024Open, Classified

    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 information on this potential device interaction.

    Z-2965-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

27. Aug 5, 2024Open, Classified

    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 information on this potential device interaction.

    Z-2964-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

28. Aug 5, 2024Open, Classified

    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 information on this potential device interaction.

    Z-2963-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

29. Aug 5, 2024Open, Classified

    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 information on this potential device interaction.

    Z-2959-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

30. May 31, 2024Open, Classified

    Nine (9) Impella CP pumps failed inspection and were inadvertently released.

    Z-2319-2024 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

…and 16 older recalls, listed on each model's page.

Most reported Impella Heart Pump problems

Impella Heart Pump models

34 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Impella 0048-0045

  Temporary Non-Roller Type Left Heart Support Blood Pump
  5 recalls1,269 deaths11,112 reports
• Impella 1000100

  Temporary Non-Roller Type Left Heart Support Blood Pump
  5 recalls848 deaths6,093 reports
• Impella 1000080

  Temporary Non-Roller Type Left Heart Support Blood Pump
  7 recalls987 deaths5,084 reports
• Impella 0042-0000-US

  Temporary Non-Roller Type Left Heart Support Blood Pump
  12 recalls120 deaths2,456 reports
• Impella 0042-0040-US

  Temporary Non-Roller Type Right Heart Support Blood Pump
  8 recalls41 deaths1,305 reports
• Impella 1000323

  Temporary Non-Roller Type Right Heart Support Blood Pump
  6 recalls189 deaths943 reports
• Impella 0550-0008

  Temporary Non-Roller Type Left Heart Support Blood Pump
  4 recalls87 deaths1,005 reports
• Impella Impella CP Pump Set

  Temporary Non-Roller Type Left Heart Support Blood Pump
  9 recalls9 deaths272 reports
• Impella 0042-0010-US

  Temporary Non-Roller Type Left Heart Support Blood Pump
  7 recalls6 deaths284 reports
• Impella 004334

  Temporary Non-Roller Type Right Heart Support Blood Pump
  3 recalls61 deaths408 reports
• Impella 0046-0035

  Temporary Non-Roller Type Right Heart Support Blood Pump
  4 recalls37 deaths258 reports
• Impella Impella 5.0 AIC Pump Set

  Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
  3 recalls56 deaths256 reports
• Impella 0048-0024

  Temporary Non-Roller Type Left Heart Support Blood Pump
  2 recalls40 deaths296 reports
• Impella Impella 2.5 AIC Pump Set

  Temporary Non-Roller Type Cardiac Support Blood Pump
  3 recalls23 deaths185 reports
• Impella Impella LD AIC Pump Set

  Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
  3 recalls9 deaths57 reports
• Impella 0048-0032

  Temporary Non-Roller Type Left Heart Support Blood Pump
  3 recalls3 deaths42 reports
• Impella 1000550

  Introducer, Catheter
  1 recall10 deaths92 reports
• Impella 0048-0003

  Temporary Non-Roller Type Left Heart Support Blood Pump
  6 deaths124 reports
• Impella 1000200

  Temporary Non-Roller Type Left Heart Support Blood Pump
  9 deaths84 reports
• Impella 0043-0003

  Temporary Non-Roller Type Left Heart Support Blood Pump
  1 recall7 reports
• Impella 1000441

  Introducer, Catheter
  1 recall5 reports
• Impella CP with SmartAssist 1000413

  Temporary Non-Roller Type Left Heart Support Blood Pump
  1 recall1 death5 reports
• Impella 1000434

  Introducer, Catheter
  1 recall1 report
• Impella 0052-0038

  Introducer, Catheter
  1 recall0 reports
• Impella 0052-0039

  Introducer, Catheter
  1 recall0 reports
• Impella 1000534

  Introducer, Catheter
  1 recall0 reports
• Impella 1000535

  Introducer, Catheter
  1 recall0 reports
• Impella 1000457

  Introducer, Catheter
  1 recall0 reports
• Impella 0052-3005

  Temporary Non-Roller Type Left Heart Support Blood Pump
  1 death27 reports
• Impella RP Flex Introducer Kit 2000342

  Introducer, Catheter
  3 deaths9 reports
• Impella 0052-3018

  Temporary Non-Roller Type Left Heart Support Blood Pump
  6 reports
• Impella 0052-0011

  Introducer, Catheter
  1 death3 reports
• Impella 0052-0002

  Introducer, Catheter
  1 death1 report
• Impella 0052-3068

  Introducer, Catheter
  1 report

Recent Impella Heart Pump adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50955044 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis; Renal Failure

  MAUDE report 50954936 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951662 ↗
• MalfunctionSep 30, 2026Application Network Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951369 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50950903 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50949742 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  The complainant reported that a patient was implanted with an Impella CP via percutaneous left femoral artery for mechanical circulatory support. Placement signal not reliable was reported on the Automated Impella Controller (AIC) screen. The placement signal waveform was not visible on the AIC screen after the issue occurred. The pump's position was confirmed via echocardiogram. The procedure was successful with this device. The device was not removed due to the failure. The patient remains on support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949332 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 50948963 ↗
• MalfunctionSep 30, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948926 ↗
• InjurySep 30, 2026Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948875 ↗
• MalfunctionSep 30, 2026False Alarm; Device Sensing Problem

  The complainant reported that a patient was implanted with an Impella 5.5 via right surgical axillary/subclavian artery for mechanical circulatory support. The patient¿s registered nurse (RN) called to say that the patient kept getting Impella in aorta and Impella position unknown alarms then resolving. They did an echocardiogram and the device position looked good per the team. The patient¿s RN stated no drops in flows, changes in blood pressure, or loss of pulsatility when the alarms occur. The medical doctor made the decision to disable placement signal alarms. The patient's outcome was stable. The patient remains on support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948773 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis; Ischemia

  MAUDE report 50948624 ↗
• InjurySep 30, 2026Failure to Advance

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50948527 ↗
• MalfunctionSep 30, 2026Deformation Due to Compressive Stress; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948502 ↗
• MalfunctionSep 30, 2026Difficult to Remove

  It was reported that the pump was originally pre-closed with per close two times. Upon insertion Abiomed representative instructed the physician that per close was not part of our IFU recommendations. The physician insisted on placing two anyway with acknowledgment of the risks. Upon successful wean and attempt to explant after removal of the repositioning sheath, there was resistance met at the motor housing portion of the pump removal. It was determined by the physician that the per close devices had been tightened around the catheter, and therefore the vein puncture site was not large enough to fit the motor out of the vein. The Abiomed representative was notified and they discussed that the safest option would more than likely be a cut down to remove the pump safely from the patient. Ultimately the physician was able to break the per close knot and remove the pump safely from the patient and removed the pump safely from the patient. No allegations were made against the device or the devices function with the doctor acknowledging that it was the result of the physician tightening the knots. Patient safe and stable at end of procedure. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947993 ↗