Impella 0043-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813502011135), received between Dec 2, 2025 and Sep 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

26 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 16, 2026.

Recalls naming this device

1. Feb 18, 2026Open, Classified

   Increased risk of purge leaks with Generation 1 purge cassettes.

   Z-1589-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773953 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  PATIENT IS A 33Y/O FEMALE WITH PMH OF OBESITY, PERIPARTUM CM AND HTN WHO ARRIVED TO THE OR THIS EVENING IN WORSENING CARDIOGENIC SHOCK WITH PLANS OF UPGRADING FROM IABP TO IMPELLA 5.5. IMPELLA WAS PREPPED AND INSERTED SUCCESSFULLY PER IFU PROTOCOL UNDER FLUOROSCOPY AND TEE VIA RIGHT AXILLARY ARTERY. IMPELLA WAS TURNED ON TO P6 WITH FLOWS OF 3.5L/MIN AND IABP WAS SUBSEQUENTLY REMOVED. PT SENT TO ICU IN STABLE CONDITION. IMPELLA PURGE CARTRIDGE NOTED TO HAVE A SMALL LEAK. NO INTERVENTION WAS NEEDED AS LEAK WAS VERY SMALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714377 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  A PURGE CASSETTE WAS IDENTIFIED AS DEFECTIVE DUE TO PURGE LEAKAGE OBSERVED AROUND THE CASSETTE, WHICH TRIGGERED A DEFECTIVE PURGE CASSETTE ALARM. THE CASSETTE WAS REPLACED, AND THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625948 ↗
• MalfunctionMar 10, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT AN AUTOMATED IMPELLA CONTROLLER FAILED TO RECOGNIZE A PURGE CASSETTE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557110 ↗
• MalfunctionMar 7, 2026Failure to Read Input Signal

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT.   CASSETTES DID NOT REGISTER WHEN PUT INTO THE CONTROLLER. THE PURGE CASSETTE WAS CHANGED TWICE AND THE THIRD PURGE CASSETTE WAS RECOGNIZED BY THE CONTROLLER. THE CASE WAS COMPLETED AND THE PATIENT DID VERY WELL. NO PATIENT HARM WAS REPORTED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539890 ↗
• MalfunctionFeb 16, 2026Appropriate Device Problem Term/Code Not Available; Priming Problem

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. STAFF INDICATED THAT THEY WERE UNCERTAIN WHETHER THE INITIAL PURGE PROCESS WAS INITIATED WHILE THE DEVICE WAS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344264 ↗
• MalfunctionDec 2, 2025Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. (B)(6) 2025, P-00748088; TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS BEING PERFORMED AND IMAGING SHOWED APPROPRIATE IMPELLA ORIENTATION AND POSITIONING. HAD 2 BOUTS OF SUSTAINED VENTRICULAR FIBRILLATION (VF) REQUIRING DEFIBRILLATION TWICE DURING ECHOCARDIOGRAM (ECHO). OVERNIGHT, THE PATIENT WAS HYPOTENSIVE AND REQUIRED SIGNIFICANT INCREASE IN VASOACTIVE-INOTROPIC SCORE (VIS) BUT REMAINED AT P6. IMPELLA CONNECT CONNECTION WAS LOST OVERNIGHT. TTE ALSO SHOWED DEPLETED RIGHT ATRIUM (RA)/RV WITH VOLUME OVERLOADED LV. INCREASED SUPPORT TO P8, GIVEN ALBUMIN, START BICARBONATE DRIPS FOR METABOLIC ACIDOSIS, AND ATTEMPT TO WEAN VASOACTIVES. STARTING WITH DOBUTAMINE AND LEVOPHED NEXT. IMPELLA 5.5 SITE LOOKS GOOD WITH NO HEMATOMA. JACKSON-PRATT (JP) BULB DRAIN WITH MINIMAL OUTPUT. URINE OUTPUT MARGINAL BUT GOOD IN COLOR THAT HAS SLIGHTLY IMPROVED WITH THE INCREASE IN P-LEVEL. LACTIC WAS NORMAL. ON AMIODARONE, HEPARIN, AND PRIMACOR. (B)(6) 2025, P-00748108; THE LEFT ANTERIOR DESCENDING (LAD) HAD STENT BEFORE BUT IS CALCIFIED WITHIN THE STENT AND HAS COMPLETE TOTAL OCCLUSION. NO PLANS TO ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695294 ↗

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-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-2457-2026 · May 18, 2026 · Open, Classified
  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• Z-2360-2026 · May 14, 2026 · Open, Classified
  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; P
• Z-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• 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-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-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-0069-2026 · Oct 1, 2025 · Open, Classified
  Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product
• Z-0136-2026 · Sep 16, 2025 · Open, Classified
  Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella
• Z-2164-2025 · Jun 23, 2025 · Open, Classified
  Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella
• Z-0829-2025 · Dec 12, 2024 · Open, Classified
  Impella RP with SmartAssist; Product Number: 0046-0035;

…and 11 more.