Impella Impella CP Pump SetRecalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00813502011289), received between Aug 14, 2023 and Sep 28, 2026 — classified as 9 deaths, 2 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (83 reports).

9 FDA recall records name this device's identifier, 9 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 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. 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 ↗

4. 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 ↗

5. 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 ↗

6. 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 ↗

7. 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 ↗

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 ↗

9. 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 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926244 ↗
• MalfunctionAug 24, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410261 ↗
• MalfunctionJul 27, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037804 ↗
• MalfunctionJul 6, 2026Application Program Problem

  THE COMPLAINANT REPORTED THAT DURING SERVICING OF AN AUTOMATED IMPELLA CONTROLLER (AIC), A CONTINUOUS AUDIBLE ALARM WAS HEARD THROUGHOUT THE DEVICE STARTUP PROCESS. FOLLOWING STARTUP, A YELLOW "CONTROLLER ERROR" WARNING MESSAGE WAS DISPLAYED ON THE HOME SCREEN. THE CONDITION WAS IDENTIFIED DURING DEVICE EVALUATION AND NOT DURING PATIENT TREATMENT. NO PATIENT INVOLVEMENT OCCURRED, AND 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 25718418 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem

  THE COMPLAINANT REPORTED THAT DURING SERVICE AND REPAIR ACTIVITIES, AN AUTOMATED IMPELLA CONTROLLER (AIC) UNDERWENT PREVENTIVE MAINTENANCE AND FAILED THE PROCEDURE. DURING EVALUATION, IT WAS OBSERVED THAT THE COOLING FAN WAS NOT FUNCTIONING AS EXPECTED, WITH OPERATION LIMITED TO ONE SIDE. NO ADDITIONAL INFORMATION REGARDING TROUBLESHOOTING OR CORRECTIVE ACTIONS WAS AVAILABLE. 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 25638810 ↗
• MalfunctionJun 8, 2026Application Network Problem

  THE COMPLAINANT REPORTED THAT DURING CLINICAL USE OF AN AUTOMATED IMPELLA CONTROLLER (AIC), INTERMITTENT CONNECTIVITY ISSUES WERE OBSERVED WITH IMPELLA CONNECT. THE CONTROLLER WAS REPORTED TO CONNECT TO THE SYSTEM AND SUBSEQUENTLY DISCONNECT, THEN RECONNECT INTERMITTENTLY. A SEPARATE IMPELLA CP DEVICE WAS ALSO INVOLVED IN THE PROCEDURE; HOWEVER, THAT DEVICE WAS NOT UTILIZED DUE TO PRIMING ISSUES, AND A SEPARATE MDR HAS BEEN SUBMITTED FOR THAT EVENT. 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 25430500 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  THE COMPLAINANT REPORTED THAT DURING SERVICE AND REPAIR ACTIVITIES, AN AUTOMATED IMPELLA CONTROLLER (AIC) UNDERWENT PREVENTIVE MAINTENANCE. DURING INSPECTION, THE PURGE FLAG WAS FOUND TO BE BROKEN. THE PURGE FLAG WAS REPLACED. FOLLOWING REPLACEMENT, THE CONTROLLER WAS TESTED AND WAS REPORTED TO BE FUNCTIONING AS EXPECTED. 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 25335306 ↗
• MalfunctionMay 18, 2026Electrical /Electronic Property Problem

  THE COMPLAINANT REPORTED THAT DURING SERVICE AND REPAIR ACTIVITIES, AN AUTOMATED IMPELLA CONTROLLER (AIC) FAILED THE PREVENTIVE MAINTENANCE PROCEDURE. UPON POWER-UP, THE CONSOLE DISPLAYED A ¿BATTERY FAILURE¿ ALARM. 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 25200921 ↗
• MalfunctionMar 31, 2026Battery Problem

  THE CONSOLE WAS RETURNED TO FIELD SERVICE FOR ANNUAL PREVENTIVE MAINTENANCE. UPON INITIAL STARTUP, A RED BATTERY FAILURE ALARM WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741052 ↗
• MalfunctionMar 23, 2026Computer Operating System Problem

  THE COMPLAINANT REPORTED THAT THE CONSOLE DISPLAYED A SYSTEM SELF-CHECK FAILURE AFTER INITIAL STARTUP DURING PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664099 ↗
• MalfunctionMar 19, 2026Computer Operating System Problem

  IT WAS REPORTED THAT THE CLINIC WANTED TO CONDUCT A TRAINING SESSION AT THE AUTOMATED IMPELLA CONTROLLER (AIC). UPON STARTING THE AIC, THE SYSTEM FAILED TO BOOT AND THE CONSOLE RECOMMENDED SWITCHING TO A DIFFERENT CONSOLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639584 ↗
• MalfunctionMar 10, 2026Connection Problem

  THE COMPLAINANT REPORTED AN OPTICAL SENSOR ISSUE ACCOMPANIED BY A YELLOW NOTIFICATION ON THE AUTOMATED IMPELLA CONTROLLER (AIC) SCREEN. THE ISSUE WAS RESOLVED BY RECONNECTING THE CABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561498 ↗
• MalfunctionMar 9, 2026Key or Button Unresponsive/not Working

  THE GREY BUTTON OF THE AIC DID NOT WORK. IT WAS NECESSARY TO DETACH THE GREY BUTTON FOR SETTING UP THE AUTOMATED IMPELLA CONTROLLER WITH THE SMALL METAL PIN. THE PROCEDURE WAS SUCCESSFUL WITH THIS DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549356 ↗
• MalfunctionFeb 26, 2026Device Sensing Problem

  DURING IMPELLA CP SUPPORT, THE PATIENT EXPERIENCED A WRONG PLACEMENT SIGNAL. CLINICIAN STATED THAT THE PLACEMENT SIGNAL OF THE OPTICAL SENSOR WAS 20/20 MMHG WICH WAS DIFFERENT FROM PATIENTS ACTUAL BLOOD PRESSURE UPON IMPLANT AND FOR DURATION OF CASE. THERE WERE NO CONSEQUENCES NOTED FOR THE PATIENT AND THE CASE. THIS IS CONSIDERED A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462337 ↗
• InjuryFeb 25, 2026Application Program Problem

  CLINICAL RATIONALE: AFTER SWITCHING ON, THE AIC DISPLAYED A ¿CONTROLLER ERROR¿ ALARM. THE AIC WAS REPLACED, AND SUPPORT CONTINUED. THE REPORTED EVENTS INCLUDE CONTROLLER FAILURE, DEVICE REVISION OR REPLACEMENT, AND HEMODYNAMIC INSTABILITY. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS.

  Patient problems: Hemodynamic instability

  MAUDE report 24442256 ↗
• MalfunctionFeb 23, 2026Application Program Problem

  THE COMPLAINANT REPORTED THAT DURING PREPARATION OF THE CATHETERIZATION LABORATORY, AN AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED A YELLOW CONTROLLER ERROR UPON POWER-UP, INSTRUCTING STAFF TO USE A BACKUP CONTROLLER. THE AIC WAS SUBSEQUENTLY POWERED OFF, AND A BACKUP CONTROLLER WAS PREPARED FOR THE UPCOMING CLINICAL PROCEDURE. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE, AND NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414519 ↗
• MalfunctionFeb 3, 2026Application Program Problem

  CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 64-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). DURING SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) REQUIRED REPLACEMENT. THE REPORTED EVENTS ARE CONTROLLER FAILURE, DEVICE REVISION OR REPLACEMENT, MEDICAL DEVICE REMOVAL, AND HEMODYNAMIC INSTABILITY. ALTHOUGH THE CASE IS CODED AS PRODUCT MALFUNCTION, THE IMPELLA CP IS BEING CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO A TEMPORARY INTERRUPTION OF HEMODYNAMIC SUPPORT DURING THE CONSOLE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND HEMODYNAMIC SUPPORT WAS RESUMED.

  Patient problems: Hemodynamic instability; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245536 ↗
• MalfunctionJan 29, 2026Failure to Read Input Signal; Priming Problem

  THE COMPLAINANT REPORTED THAT THE PURGE CASSETTE WAS INSERTED BUT NOT RECOGNISED. THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED THE FOLLOWING ALARM: PURGE FLUID NOT RECOGNIZED. NEITHER THE CASSETTE NOR THE PURGE LINE WERE FLUSHED. THE PURGE CASSETTE WAS THEN REPLACED AND THE PROCEDURE COULD CONTINUE. THE PUMP COULD THEN BE FLUSHED AND IMPLANTED WITHOUT ANY PROBLEMS. THE PATIENT SUFFERED NO HARM. THE CUSTOMER SAID THAT THIS PROBLEM HAS OCCURRED SEVERAL TIMES ON THIS AIC. THEREFORE, IS SENDING THE AIC IN FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218366 ↗
• MalfunctionJan 26, 2026Power Problem

  IT WAS REPORTED THAT AN AUTOMATED IMPELLA CONTROLLER ENTERED BATTERY MODE DESPITE BEING PERMANENTLY CONNECTED TO THE ELECTRICAL CURRENT, THEN SPONTANEOUSLY RETURNED TO RECEIVING ELECTRICAL POWER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177102 ↗
• MalfunctionJan 15, 2026Computer Operating System Problem

  THE COMPLAINANT REPORTED THAT THEY WERE UNABLE TO PERFORM SELF TEST OF THE AUTOMATED IMPELLA CONTROLLER. SYSTEM SELF-CHECK ERROR OCCURRED. A REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080160 ↗
• MalfunctionJan 9, 2026Computer Operating System Problem

  THE USER FACILITY REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER HAD A SYSTEM SELF CHECK FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021228 ↗
• MalfunctionJan 5, 2026Battery Problem

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE BATTERY HAD AN ISSUE ON ALARM, AND NO INFORMATION ABOUT ERROR CODE. SUBSEQUENTLY THEY SWITCHED THE AUTOMATED IMPELLA CONTROLLER (AIC), AS FOLLOWS THERE IS A NEED OF REPLACEMENT OF THE DEVICE. NO PATIENT INJURY WAS REPORTED. THE PATIENT OUTCOME IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961150 ↗
• MalfunctionDec 24, 2025Application Program Problem; Application Program Problem

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER SHOWED "FAILURE SYSTEM, PLEASE SWITCH TO BACK UP CONTROLLER". THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889571 ↗
• MalfunctionDec 24, 2025Computer Operating System Problem; Operating System Becomes Nonfunctional; Computer Operating System Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING CUSTOMER TRAINING THE AUTOMATED IMPELLA CONTROLLER SCREEN FROZE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888673 ↗
• MalfunctionDec 12, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER HAD A SELF CHECK FAILURE UPON START UP. THE CONTROLLER WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788573 ↗