Impella 1000200Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00813502012477), received between Jan 28, 2026 and Sep 25, 2026 — classified as 9 deaths, 5 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Priming Problem” (39 reports).

27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that a patient implanted with an Impella CP experienced a leak at the Luer-lock connection of the sidearm, and a leak was in the tubing of the purge cassette. As the patient was already undergoing weaning and Impella explant was planned, no new purge cassette was connected or tested. The existing support was continued until the planned explant. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896612 ↗
• MalfunctionSep 25, 2026Priming Problem

  It was reported that during a purge cassette change, the replacement cassette failed to purge. Multiple de-airing cycles were attempted without success. A new cassette was used successfully. No patient harm was reported and Impella support continues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896545 ↗
• MalfunctionSep 24, 2026Decrease in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888805 ↗
• MalfunctionSep 24, 2026Increase in Pressure

  The complainant reported that, during a protected percutaneous coronary intervention, there was no flow by purge and high purge pressure. No patient harm has been reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886215 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842026 ↗
• MalfunctionSep 16, 2026Wrong Label

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796683 ↗
• MalfunctionAug 25, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439167 ↗
• MalfunctionAug 21, 2026Decrease in Pressure; Increase in Pressure; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374446 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA PUMP EXPERIENCED A HEMATOMA AT THE ACCESS SITE. THE HEMATOMA WAS RESOLVING AND THE PATIENT WAS IN STABLE CONDITION. IMPELLA SUPPORT CONTINUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456377 ↗
• MalfunctionJun 2, 2026Decrease in Pressure

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PURGE PRESSURE WENT DOWN AND THE FLOW TO 30. THE NURSE CHANGED THE PURGE CASSETTE AND THE PROBLEM RESOLVED. THERE WAS NO PATIENT HARM. AT THIS TIME, THE PATIENT IS STILL ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361801 ↗
• MalfunctionMay 20, 2026Priming Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED AIR IN THE PURGE SYSTEM. A DEAIRING WAS PERFORMED WITHOUT SUCCESS. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229389 ↗
• MalfunctionMay 11, 2026Priming Problem

  THE COMPLAINANT REPORTED THAT DURING PREPARATION OF AN IMPELLA CP, A SMALL AMOUNT OF AIR ACCUMULATION WAS OBSERVED AT THE CONNECTION BETWEEN THE YELLOW LUER OF THE PURGE CASSETTE AND THE PURGE CASSETTE EXTENSION TUBING. IT WAS ALSO NOTED THAT THE YELLOW LUER CONNECTION WAS NOT FULLY TIGHTENED AT THE TIME THE PURGE CASSETTE WAS REMOVED FROM THE PACKAGING. THE YELLOW LUER CONNECTION WAS SECURED, AND A SNAPPING SENSATION WAS NOTED UPON PROPER ENGAGEMENT. FOLLOWING THIS ADJUSTMENT, THE AIR WAS FLUSHED FROM THE SYSTEM, AND PREPARATION WAS COMPLETED WITHOUT FURTHER ISSUE. 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 25135129 ↗
• MalfunctionMay 11, 2026Priming Problem

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP VIA RIGHT PERCUTANEOUS FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. THE CUSTOMER ATTEMPTED TO PRIME THE PUMP AND THE PURGE SPIKE WOULD NOT PULL THE FLUID FROM THE FLUID BAG. UPON SWITCHING TO A NEW CASSETTE, THE PRIME WORKED FINE. AN ALARM PRODUCED A READ OF ¿PURGE FLUID NOT DETECTED¿. THIS CLEARED WHEN A NEW PURGE SYSTEM WAS CONNECTED. NO PATIENT HARM WAS NOTED AND THE PATIENT SURVIVED. THE PROCEDURE WAS SUCCESSFUL WITH THE OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135121 ↗
• MalfunctionMay 7, 2026Failure to Read Input Signal; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED A CRACK IN THE PURGE RESERVOIR ASSOCIATED WITH PURGE ALARMS. AN ALTERNATIVE PURGE SYSTEM WAS PUT INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110789 ↗
• MalfunctionMay 4, 2026Decrease in Pressure

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THERE WERE FREQUENT PURGE FLOW INCREASED AND DECREASED WHITE ALERTS. NO RED ALARMS. SURGEON AWARE, NO INTERVENTION AT THIS TIME. PF FLUCTUATES 8-13 ML/HR. PP OCCASIONALLY DROPS TO 20 MMHG BUT RECOVERS. DID NOT CHANGE AFTER CASSETTE CHANGE. NO LEAKS OR CRACKS OBSERVED AT CONNECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072796 ↗
• MalfunctionMay 4, 2026Failure to Read Input Signal

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE NURSE CALLED TO REPORT NEW INTERMITTENTLY ALARMING PSNR ALARM. PER REPORT, PATIENT IS RESTING AND STILL IN BED. NO ADDITIONAL DETAILS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072005 ↗
• MalfunctionApr 30, 2026Failure to Read Input Signal

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. PER THE NURSE, CARTRIDGE FAILURE OF PURGE CASSETTE THAT PROMPTED ALARM. DECISION TO REPLACE CASSETTE. THE PATIENT REMAINS ON SUPPORT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049602 ↗
• MalfunctionApr 29, 2026Priming Problem

  A 73-YEAR-OLD MAN PRESENTED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC ARREST, AND AN IMPELLA CP DEVICE WAS PLACED DURING ACTIVE RESUSCITATION. IN THE INTENSIVE CARE UNIT, A PURGE CASSETTE ERROR MESSAGE WAS OBSERVED. THE PURGE CASSETTE WAS REPLACED, AFTER WHICH THE DEVICE FUNCTIONED AS INTENDED. DESPITE CONTINUED MECHANICAL SUPPORT, THE PATIENT¿S CLINICAL CONDITION DETERIORATED WITH RECURRENT EPISODES OF CARDIAC ARREST AND ESCALATING PHARMACOLOGIC CIRCULATORY SUPPORT REQUIREMENTS. THE PATIENT SUBSEQUENTLY EXPERIENCED VENTRICULAR FIBRILLATION AND EXPIRED ON SEPTEMBER 9. THE EVENT IS BEING CONSERVATIVELY REPORTED AS A PATIENT DEATH POTENTIALLY ASSOCIATED WITH THE DEVICE; HOWEVER, BASED ON AVAILABLE INFORMATION, IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH IS BELIEVED TO BE RELATED TO THE PATIENT¿S SEVERE UNDERLYING CLINICAL CONDITION. THIS REPORT IS REGARDING THE PURGE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028600 ↗
• MalfunctionApr 22, 2026Decrease in Pressure; Priming Problem

  THE COMPLAINANT WAS IMPLANTED WITH AN IMPELLA 5.5 VIA SURGICAL AORTA FOR MECHANICAL CIRCULATORY SUPPORT. "PURGE SYSTEM AIR CONTAMINATION" AND "PURGE SYSTEM FLUID LEAK" ALTERNATELY OCCURRED. THE PURGE SET WAS REPLACED BECAUSE IT DID NOT IMPROVE EVEN THOUGH IT WAS ACCORDING TO THE CONTROL UNIT'S INSTRUCTIONS. THEN THE ALARM DISAPPEARED COMPLETELY. NO LIQUID LEAKS WERE FOUND FROM THE CONNECTING CONNECTOR AREA OR FROM THE PURGE CASSETTE AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953334 ↗
• MalfunctionApr 22, 2026Decrease in Pressure

  THE COMPLAINANT REPORTED THAT DURING IMPELLA 5.5 SUPPORT, THE PURGE CASSETTE AND ASSOCIATED TUBING WERE CHANGED. IMMEDIATELY FOLLOWING THE CHANGE, THE PURGE FLOW INCREASED FROM A BASELINE OF APPROXIMATELY 15 ML/HR TO APPROXIMATELY 30 ML/HR. A KNOCKING SOUND WAS REPORTED BY BOTH THE REGISTERED NURSE (RN) AND THE PATIENT AT THAT TIME. THE PURGE TUBING WAS SUBSEQUENTLY CHANGED AGAIN, AFTER WHICH THE ISSUE RESOLVED. THE PURGE CASSETTE WAS REPLACED, AND REPLACEMENT OF THE PURGE CASSETTE RESOLVED THE ISSUE. A ¿DEFECTIVE PURGE CASSETTE¿ CONDITION WAS REPORTED. AT THE TIME OF REPORT WRITING, THE PATIENT REMAINED ON IMPELLA 5.5 SUPPORT. 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 24952751 ↗
• MalfunctionApr 22, 2026Priming Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A IMPELLA 5.5 EXPERIENCED A FAULTY PURGE CASSETTE. THE CONTROLLER WAS EXCHANGED FOR A NEW ONE WHICH DID NOT RESOLVE THE ISSUE. WHEN THE PURGE WAS REPLACED THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952208 ↗
• DeathApr 17, 2026Priming Problem

  THE COMPLAINANT REPORTED THE PURGE CASSETTE WAS PURGED TWICE AFTER AN AIR IN PURGE ALARM OCCURRED. AFTER THE ALARM CAME BACK, THE CASSETTE WAS CHANGED. NO ISSUE SINCE, AND THE CASSETTE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916689 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  THE COMPLAINANT REPORTED THAT A PHYSICIAN INDICATED THE IMPELLA PURGE CASSETTE WAS LEAKING DURING SUPPORT WITH AN IMPELLA PUMP. A FOLLOW-UP FOR THE ISSUE WAS PERFORMED IN THE INTENSIVE CARE UNIT (ICU). AT THE TIME OF FOLLOW-UP, THE ICU TEAM WAS NOT AWARE OF AN ACTIVE LEAK, AND NO LEAKAGE WAS OBSERVED. IT WAS NOTED THAT THE PURGE CASSETTE DOCKING APPEARED STICKY. NO ALARMS WERE REPORTED ON THE SYSTEM. THE ICU TEAM WAS UNSURE WHETHER THE PURGE CASSETTE HAD ALREADY BEEN REPLACED. AT THE TIME OF REPORT WRITING, THE PATIENT REMAINED ON SUPPORT WITH THE IMPELLA PUMP. 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 24903579 ↗
• MalfunctionApr 16, 2026Break; Noise, Audible

  ADDITIONAL INFORMATION HAS BEEN PROVIDED: "NO HEPARIN WAS USED IN THE PURGE. THE PATIENT SURVIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894653 ↗
• MalfunctionApr 14, 2026Failure to Read Input Signal; Priming Problem

  IT WAS REPORTED THAT A PURGE FAILURE ALARM OCCURRED. THE AUTOMATED IMPELLA CONTROLLER AND PURGE CASSETTE WERE EXCHANGED FOR NEW ONES TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872198 ↗

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-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-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-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-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-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-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

…and 12 more.