Impella 0042-0000-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,456 adverse event reports that list this exact device (DI 00813502010022), received between Nov 21, 2016 and Sep 30, 2026 — classified as 120 deaths, 76 injuries, 2,260 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (594 reports).

12 FDA recall records name this device's identifier, 10 still open.

16 other recalls cover devices cleared under the same FDA submission (P140003, P170011); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Aug 12, 2026Class IOpen, 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 · Recall details · FDA record ↗

2. May 14, 2026Class IOpen, 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. Apr 20, 2026Class IOpen, 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 ↗

4. Feb 16, 2026Class IOpen, 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 · Recall details · FDA record ↗

5. Oct 1, 2025Class IOpen, 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 ↗

6. Sep 16, 2025Class IOpen, 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 ↗

7. Aug 20, 2025Class IOpen, 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 · Recall details · FDA record ↗

8. Jun 23, 2025Class IOpen, 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 ↗

9. Oct 10, 2023Class IITerminated

   Pump not detected as connected to controller due to software issue.

   Z-0440-2024 · Root cause: Software design · Recall details · FDA record ↗

10. Mar 1, 2021Class IITerminated

    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 ↗

11. Feb 19, 2019Class IIOpen, 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 ↗

12. Jan 17, 2011Class IOpen, Classified

    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 in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

    Z-2238-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,456 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Application Network Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951369 ↗
• 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 the purge cassette portion of the preventive maintenance procedure, the console failed testing when a crack was identified in the Purge Disk Retainer. The Purge Disk Retainer was replaced. Following replacement, the preventive maintenance procedure was completed without further issues. The console subsequently passed testing and was returned to service.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 50947927 ↗
• MalfunctionSep 30, 2026Difficult to Open or Close

  The complainant reported that a patient was implanted with an Impella device for mechanical circulatory support. The Automated Impella Controller (AIC) purge cassette door was not opening. Side button was stuck. There was no patient harm in relation to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947639 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The complainant reported that during service and repair activities, an Automated Impella Controller (AIC) underwent preventive maintenance and functional testing. During preventive maintenance, a broken cable was identified. The affected component was replaced. Following replacement, 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 50945535 ↗
• MalfunctionSep 29, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935676 ↗
• MalfunctionSep 29, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935300 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935212 ↗
• MalfunctionSep 29, 2026False Alarm; Device Sensing Problem

  Updated Clinical Narrative: Additional information provided on 24SEP2026, The suction was a false alarm. The AIC was in need of recalibration and the alarms resolved after the waveforms were calibrated. The placement signal was off by more than 40 points.Previous Clinical NarrativeAn Impella 5.5 was inserted surgically via right axillary/subclavian access site in 43-year-old male patient for Cardiomyopathy. The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage C identified as clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support and decompensated the next day to (SCAI) Shock Stage D identified as clinical evidence of shock that worsens or fails to improve despite escalation therapies. The patient was on inotropes and vasopressors.On day 19 of Impella support, the nurse reported bleeding and hematoma formation at the Impella access site following transfer to the Intensive care unit (ICU). Heparin was held and manual pressure was applied, which reportedly controlled the bleeding. Information regarding anticoagulatio

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931766 ↗
• MalfunctionSep 29, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931626 ↗
• MalfunctionSep 29, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931519 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926153 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925922 ↗
• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925286 ↗
• MalfunctionSep 28, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918092 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  The complainant reported that they were unable to turn off the console. Message pops up occurred saying Impella connected please disconnect Impella before shutdown. No Impella catheter was connected. The console was being used for competency check offs and the account was plugged in their own catheter for the check offs. Customer support was called and they were instructed to force a shutdown. The alarm cleared when the console was turned back on. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916391 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  The complainant reported that while performing a functional check, a crack was found at the head of the purge retainer. The purge retainer was replaced. The console performed to specification and was shipped for consignment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915660 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  The complainant reported that while performing preventative maintenance a crack of the purge disk retainer was found. The purge disk retainer was replaced and all specifications were passed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915514 ↗
• MalfunctionSep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914989 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914889 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  The complainant reported that the console failed preventative maintenance, Optical Bench Check - SNR Value, under tolerance. The console required replacement of the optical bench.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914331 ↗
• MalfunctionSep 28, 2026Unclear Information

  It was reported that the Impella console arrived for annual preventative maintenance service with no identification number label attached. The console UDI (unique device identifier) label was not present. There was no patient involvement in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914288 ↗
• MalfunctionSep 28, 2026Failure to Read Input Signal

  An Impella 5.5 with SmartAssist (SA) was inserted via the right axillary/subclavian artery in a 65-year-old female weighing 83 kg. The patient presented with acute myocardial infarction complicated by cardiogenic shock and cardiac arrest requiring cardiopulmonary resuscitation. Comorbidities were not reported. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Stage E cardiogenic shock, identified by refractory shock in which the body is failing to respond to maximal lifesaving therapies with progressive end-organ dysfunction. Prior to Impella support, the patient was receiving extracorporeal membrane oxygenation (ECMO), inotropes/vasopressors, and respiratory support. ECMO was the primary hemodynamic support modality. The Impella 5.5 with SmartAssist was utilized for left ventricular venting and unloading while ECMO remained the primary hemodynamic support modality.While preparing for implantation and initiation of support, the initial Automated Impella Controller (AIC) did not recognize the purge cassette/purge disc. The same purge cassette was subsequently connected to a second AIC and functioned withou

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914104 ↗
• MalfunctionSep 28, 2026Battery Problem

  It was reported that after unplugging an Automated Impella Controller from AC current, the battery immediately dropped to 50%. It resolved itself and went back to 100% and there are no other issues or alarms at this time. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913943 ↗
• MalfunctionSep 28, 2026Priming Problem; Key or Button Unresponsive/not Working

  It was reported that upon inserting the power cord of an Impella 5.5 into an Automated Impella Controller, the priming screen was skipped and the controller displayed the placement screen. A new controller was used to continue patient support. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913892 ↗
• MalfunctionSep 25, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898577 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140003, P170011. One submission often covers many models, so check the product and lot details in each record.

• Z-3150-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn
• Z-3149-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
• Z-2457-2026 · May 18, 2026 · Open, Classified
  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• Z-1589-2026 · Feb 18, 2026 · Open, Classified
  Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5
• Z-1471-2026 · Jan 27, 2026 · Open, Classified
  Impella RP. Product Code: 0046-0011.
• Z-1470-2026 · Jan 27, 2026 · Open, Classified
  Impella RP Flex with SmartAssist. Product Code: 1000323.
• Z-1469-2026 · Jan 27, 2026 · Open, Classified
  Impella RP with SmartAssist. Product Code: 0046-0035.
• Z-1030-2026 · Dec 4, 2025 · Open, Classified
  Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• Z-0830-2025 · Dec 12, 2024 · Open, Classified
  Impella RP Flex with SmartAssist; Product Number: 1000323;
• Z-0829-2025 · Dec 12, 2024 · Open, Classified
  Impella RP with SmartAssist; Product Number: 0046-0035;
• Z-2319-2024 · May 31, 2024 · Open, Classified
  Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
• Z-0980-2024 · Dec 27, 2023 · Open, Classified
  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5
• Z-0636-2024 · Dec 6, 2023 · Open, Classified
  Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
• Z-0441-2024 · Oct 10, 2023 · Terminated
  Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
• Z-1590-2023 · Apr 17, 2023 · Open, Classified
  Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (

…and 1 more.