2nd Gen CentriMag Primary Console 201-90411Recalls & reported problems

Summary

The FDA's MAUDE database contains 459 adverse event reports that list this exact device (DI 07640135140702), received between Jun 27, 2018 and Sep 18, 2026 — classified as 87 injuries, 372 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (174 reports).

1 FDA recall record name this device's identifier, 1 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. May 22, 2024Class IIOpen, Classified

   Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

   Z-2215-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 459 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826776 ↗
• MalfunctionSep 18, 2026Display Difficult to Read

  It was reported that the there was a pixelation on half of the LCD screen on the CentriMag Console. It was intended to return for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813030 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763594 ↗
• MalfunctionSep 11, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741186 ↗
• MalfunctionSep 2, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572242 ↗
• MalfunctionAug 21, 2026Display or Visual Feedback Problem; Infusion or Flow Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376735 ↗
• MalfunctionJul 28, 2026Failure to Shut Off; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058078 ↗
• MalfunctionJul 27, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045644 ↗
• MalfunctionJul 22, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25909055 ↗
• MalfunctionJul 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847010 ↗
• MalfunctionJun 19, 2026Electrical Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE CENTRIMAG STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563580 ↗
• MalfunctionJun 11, 2026Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE A S3 "EMO" PUMP ALARM, WHICH OCCURRED WITH A STRONG CHEMICAL, ELECTRICAL BURN ODOR IN THE ROOM. THE FLOWS IN RPMS NEVER CHANGED. THE SITE LOOKED UP THE ALARM AND IT INDICATED POTENTIAL PUMP FAILURE. THE SITE REPLACED THE MOTOR AND THE CONSOLE WITH A NEW ONE. THE ALARMS CLEARED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PUMP NEVER STOPPED. THEY JUST CHANGED IT OUT FOR PRECAUTIONARY PURPOSES. THE PUMP WAS RAN IN THEIR STOREROOM FOR 48 HOURS WITH NO PROBLEMS. THEY PLANNED TO RETURN THE CONSOLE AND THE MOTOR TO ABBOTT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25476643 ↗
• MalfunctionApr 22, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE CMAG CONSOLE SPEAKERS AND POWER BUTTON DID NOT FUNCTION DUE TO A DAMAGED SPS BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953516 ↗
• MalfunctionMar 19, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE 2ND GENERATION CENTRIMAG MONITOR WAS NOT MAINTAINING POWER WHEN THE LOANER CONSOLE WAS PLACED ON BATTERY. A NEW MONITOR WAS PLACED ON THE LOANER CONSOLE AND THE MONITOR CONTINUED TO SHUT OFF WHEN THE CONSOLE WAS PLACED ON BATTERY. THE INITIAL MONITOR FUNCTIONED PROPERLY ON BATTERY WITH A NEW CONSOLE. THE LOANER CONSOLE WOULD BE SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642910 ↗
• MalfunctionMar 10, 2026Insufficient Device Problem Information

  THE PRODUCT WAS REMOVED FROM USE. THE VAD COORDINATOR SUGGESTED THAT THERE MIGHT BE POSSIBILITY THAT THE PINS WERE BENT AND THIS WAS A SUSPECTED REASON THAT THE CENTRIMAG MOTOR WAS MALFUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561928 ↗
• MalfunctionMar 9, 2026Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR AND CONSOLE WERE ON A CIRCUIT IN WHICH THE HEATER AND COOLER MAY HAVE HAD CAUSED AN ELECTRICAL SHORTAGE WITH A BURNING SMELL. THE CONSOLE AND MOTOR WERE EXCHANGE AS A PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551910 ↗
• MalfunctionMar 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PRIMING THE CONSOLE HAD AN S3 ALARM. THE MOTOR AND CONSOLE WERE REMOVED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524190 ↗
• MalfunctionMar 5, 2026Circuit Failure; No Apparent Adverse Event

  IT WAS REPORTED THAT A RENTAL CENTRIMAG CONSOLE AND MOTOR WERE ON A CIRCUIT IN WHICH THE HEATER COOLER WAS SUSPECTED TO HAVE CAUSED AN ELECTRICAL SHORTAGE. THERE WAS A BURNING SMELL, AND THE RENTAL WERE SAID TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524118 ↗
• MalfunctionFeb 20, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THE CENTRIMAG CONSOLE WAS DISPLAYING AN F4 ALARM. THE UNIT WOULD BE RETURNING, AND NO FURTHER INFO WAS AVAILABLE FROM BIO-MED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405100 ↗
• MalfunctionFeb 18, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CENTRIMAG PRIMARY CONSOLE DID NOT MEET IEC 61000-4-5 STANDARDS DURING ITS YEARLY FUNCTIONAL CHECKOUT. THE DEVICE WAS RETAINED BY TECH SERVICES FOR REWORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379823 ↗
• MalfunctionFeb 11, 2026Infusion or Flow Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE THE PATIENT WAS POWERING ON/PRIMING THE CENTRIMAG SYSTEM, THE CONSOLE DISPLAYED M3, S3, AND F2 ALARM/ALERTS. ALARM/ALERTS WERE UNABLE TO BE CLEARED. THE SITE SWITCHED TO THE BACKUP CONSOLE. THE SYSTEM WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313849 ↗
• MalfunctionFeb 6, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE FAILED DURING ITS YEARLY FUNCTIONAL CHECKOUT. IT DID NOT MEET IEC 61000-4-5 STANDARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284059 ↗
• MalfunctionFeb 4, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING THE CONSOLE DID NOT MEET IEC 61000-4-5 STANDARDS FOR SURGE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258103 ↗
• MalfunctionFeb 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PERSISTENT S3 ALARM WAS NOTED ON POWER ON PRIOR TO INITIATING SUPPORT. THE SYSTEM WAS SWITCHED TO BACK-UP CONSOLE AND MOTOR. GIVEN EQUIPMENT AGE, A COMPLETE SYSTEM REPLACEMENT WAS PERFORMED. THERE WAS NO PATIENT INVOLVED. ALL EQUIPMENT WAS BEING REPLACED DUE TO AGE BEING PAST MAX PRODUCT LIFE. NO LOG FILES WOULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241393 ↗
• MalfunctionJan 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN S3 ALARM OCCURRED DURING A PATIENT TRANSPORT WITHIN A HOSPITAL. THE CUSTOMER STATED THAT WHILE TRANSPORTING A CENTRIMAG VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV-ECMO) PATIENT, THE CENTRIMAG CONSOLE WAS PLUGGED INTO A BATTERY BACKUP/POWER STRIP DEVICE. THE S3 ALARM DID NOT RESOLVE WHEN THEY PLUGGED THE BATTERY BACKUP DEVICE INTO A HOSPITAL EMERGENCY OUTLET. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE POWER STRIP AND TO SWITCH TO ANOTHER CENTRIMAG CONSOLE AND MOTOR THAT WAS PLUGGED DIRECTLY INTO A RED HOSPITAL AC POWER OUTLET. THE CUSTOMER STATED THAT THEY DID NOT WANT TO SWITCH TO ANOTHER DEVICE AT THIS TIME AS THE PATIENT WAS CONSIDERED A DO NOT RESUSCITATE (DNR) AND THAT SOMEHOW SWITCHING TO ANOTHER DEVICE WOULD BE A PROBLEM. SEVERAL HOUR LATER THE CUSTOMER SWITCHED TO ANOTHER CENTRIMAG CONSOLE YET CONTINUED TO USE THE BATTERY BACKUP/POWER STRIP DEVICE AND THE 2ND CENTRIMAG SYSTEM ALSO DISPLAYED AN S3 ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217901 ↗