Impella 0042-0040-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,305 adverse event reports that list this exact device (DI 00813502011401), received between Aug 4, 2023 and Sep 30, 2026 — classified as 41 deaths, 62 injuries, 1,202 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (277 reports).

8 FDA recall records name this device's identifier, 6 still open.

19 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-3150-2026 · 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. 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 ↗

4. 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 ↗

5. 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 ↗

6. Oct 10, 2023Class IITerminated

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

   Z-0441-2024 · Root cause: Software design · Recall details · FDA record ↗

7. 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 ↗

8. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,305 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947866 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937296 ↗
• InjurySep 29, 2026Device Sensing Problem

  An Impella CP with SmartAssist (SA) was inserted via the right femoral artery in a 42-year-old male weighing 127 kg and measuring 188 cm in height. The patient presented with acute myocardial infarction complicated by cardiogenic shock. Comorbidities were not reported. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D identified when there is evidence of shock that worsens or fails to improve despite escalation therapies. Prior to Impella support, the patient was receiving inotropes, vasopressors, and respiratory support.Device Course & Treatment:During implantation, a 0.035-inch guidewire was unable to make the turn into the aortic arch and a 0.018-inch guidewire was subsequently used for aortic valve assessment. While the guidewire was being advanced, it contacted the Impella motor, resulting in fraying and fracture of the wire. During removal, the guidewire became entangled within the mitral valve chordae and subsequently fractured. Multiple attempts were made to snare the fractured guidewire fragment, which was ultimately successfully retrieved and removed from the patient. The Impella C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936087 ↗
• MalfunctionSep 29, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933718 ↗
• MalfunctionSep 29, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932302 ↗
• MalfunctionSep 29, 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 50932095 ↗
• MalfunctionSep 29, 2026Battery Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931952 ↗
• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925630 ↗
• MalfunctionSep 28, 2026Application Program Problem

  The complainant reported that, after providing patient care, the pump alarmed ¿controller error¿. The bedside nurse assessed the Impella cord. After applying pressure to Impella plug into console, alarm resolved. No adverse effect on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923989 ↗
• MalfunctionSep 28, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917594 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916108 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914757 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899174 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  It was reported that, while a performing preventative maintenance procedure, the console displayed a batter failure alarm after power up. The console batteries (0042-3016) were replaced. During that same preventative maintenance procedure that a hairline crack was found in the purge retainer (b)(6). The purge retainer was replaced. The console was returned back to specification and was shipped back to customer. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898466 ↗
• MalfunctionSep 25, 2026Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897750 ↗
• MalfunctionSep 25, 2026Material Integrity Problem

  It was reported that, while performing a functional check, a crack found in the purge disk retainer. The purge disk retainer (3001195) was replaced and passed all specifications. No patient harm has been reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897477 ↗
• MalfunctionSep 25, 2026Material Integrity Problem

  It was reported that, while performing a functional check, a crack was found in the purge retainer ((b)(6)). The purge retainer was replaced and the console performed to specification and was shipped back to the customer. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897163 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889340 ↗
• MalfunctionSep 24, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889055 ↗
• MalfunctionSep 24, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889043 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  It was reported that, while performing preventative maintenance, a failed measurement at 128 mmHg spec <125 was noted. The purge pressure sensor (b)(6) was replaced and the device was returned to specification. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888973 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888129 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  The complainant reported that while performing preventative maintenance a crack purge disk retainer was found and the purge film was damaged. The purge disk retainer and purge disk film were replaced. The retainer was torqued to specification and failed measurement at three mmHg spec 0 mmHg +/- 1. After replacing the purge pressure sensor, all specifications were passed. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883107 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  During service repair, a crack was identified in the purge retainer. Purge retainer was replaced. No patient involvement has been reported.Purge pressure sensor kit was also replaced due to the volume of dextrose.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883011 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  The complainant reported that the console failed preventative maintenance (PM) due to a crack in the Purge Disk Retainer. The Purge Disk Retainer was replaced. After replacing the retainer, the PM was completed with no further issues. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882915 ↗

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-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-3148-2026 · Aug 12, 2026 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 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-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• 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-1591-2026 · Feb 16, 2026 · Open, Classified
  Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Contr
• Z-1469-2026 · Jan 27, 2026 · Open, Classified
  Impella RP with SmartAssist. Product Code: 0046-0035.
• Z-1470-2026 · Jan 27, 2026 · Open, Classified
  Impella RP Flex with SmartAssist. Product Code: 1000323.
• Z-1471-2026 · Jan 27, 2026 · Open, Classified
  Impella RP. Product Code: 0046-0011.
• Z-1030-2026 · Dec 4, 2025 · Open, Classified
  Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• Z-0829-2025 · Dec 12, 2024 · Open, Classified
  Impella RP with SmartAssist; Product Number: 0046-0035;
• Z-0830-2025 · Dec 12, 2024 · Open, Classified
  Impella RP Flex with SmartAssist; Product Number: 1000323;
• 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.

…and 4 more.