Impella 0042-0010-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00813502010985), received between Aug 9, 2023 and Sep 30, 2026 — classified as 6 deaths, 9 injuries, 269 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (69 reports).

7 FDA recall records name this device's identifier, 6 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

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

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. Mar 1, 2021Terminated

   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.

   Z-1175-2024 · Root cause: Software design · Recall details · FDA record ↗

7. Feb 19, 2019Open, Classified

   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 unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

   Z-3251-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Integrity Problem

  The complainant reported that during service and repair activities, an Automated Impella Controller (AIC) underwent preventive maintenance and functional testing. During preventive maintenance, it was identified that the line cord was missing. A new line cord was installed. Following installation, the console successfully completed testing and performed within specifications.The issue was identified during service and repair activities and not during clinical use. No patient involvement was reported in association with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946764 ↗
• MalfunctionSep 29, 2026Operating System Becomes Nonfunctional

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932755 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  The complainant reported that while performing functional testing, a failed measurement at 2.6¿W Power Level >2.7 was noted. When replacing the lamp, the screw was found stripped. The optical bench was replaced with a reading of 3.9¿W and all specifications were passed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916930 ↗
• MalfunctionSep 28, 2026Computer Operating System Problem

  It was reported that when a user wanted to start the Automated Impella Controller (AIC) for a customer training, the console showed: "System check failed. Replace the console immediately¿. There was no patient involvement in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914126 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902598 ↗
• MalfunctionSep 25, 2026Application Program Problem

  The complainant reported that during clinical use of an Automated Impella Controller (AIC), a yellow controller error was displayed on the console. Due to the reported condition, the AIC was replaced with another controller. No signs or symptoms of patient injury or patient harm were reported in association with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896652 ↗
• MalfunctionSep 25, 2026Application Program Problem

  The complainant reported that during clinical use of an Automated Impella Controller (AIC), a controller error was displayed on the console. Due to the reported condition, the AIC was replaced with another controller. No additional information regarding the reported controller error or troubleshooting performed was provided.No signs or symptoms of patient injury or patient harm were reported in association with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896281 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888861 ↗
• MalfunctionSep 22, 2026Material Integrity Problem

  It was reported that the console failed during preventative maintenance of the 10 Purge Cassette. It was also noted that the Purge Disk Retainer was cracked. The Purge Disk Retainer (3001195) was replaced. After replacing the retainer, the preventative maintenance was completed with no further issues. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853932 ↗
• MalfunctionSep 2, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563207 ↗
• MalfunctionAug 27, 2026Failure to Read Input Signal

  Clinical Narrative:Impella 5.5 was inserted via right axillary surgical artery access in a 51-year-old male patient presenting with acute myocardial infarction and cardiogenic shock. The patient was classified as SCAI Shock Stage C and was receiving inotropic and vasopressor support prior to device implantation.After 7 days of support, a purge fluid leak was observed. The operator replaced the purge cassette; however, the newly installed purge disc subsequently failed. The Automated Impella Controller (AIC) was replaced and support was restored. Although there was a temporary interruption in hemodynamic support during the exchange, no patient harm, injury, or clinical sequelae were reported.After 8 days of support, the patient experienced sustained ventricular tachycardia and was successfully cardioverted. During the same period, neurological changes raised concern for a possible embolic stroke. No intervention for the neurological event was reported, and Impella support was continued.On day 14, the patient's care was escalated with the addition of extracorporeal membrane oxygenation (ECMO).Throughout support, the device functioned as intended at Performance Level P-8 with reported

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472067 ↗
• MalfunctionAug 26, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457489 ↗
• MalfunctionAug 26, 2026Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456144 ↗
• MalfunctionAug 24, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407834 ↗
• MalfunctionAug 19, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323074 ↗
• MalfunctionAug 4, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129733 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE WAS PERFORMED IN THE FIELD. THE PREVENTIVE MAINTENANCE WAS SUBSEQUENTLY VOIDED AFTER A YELLOW CONTROLLER ALARM WAS TRIGGERED FOLLOWING A REBOOT. UPON INSPECTION, A LOOSE OPTICAL FIBER WAS IDENTIFIED ON THE OPTICAL BENCH, AND THE OPTICAL BENCH WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679511 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE PURGE UNIT DRIVER WAS REPLACED ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679150 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE POWER VALUE WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678932 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE LAMP WAS REPLACED ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678583 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE HAD PREVENTIVE MAINTENANCE STEP FAILED. THE I/O PANEL WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678008 ↗
• MalfunctionJul 1, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS FAILED THE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677919 ↗
• MalfunctionJul 1, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE HAD FAILED THE SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677849 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE PBM WAS REPLACED ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677774 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS FOUND TO HAVE A DEFECTIVE PURGE ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677721 ↗