CENTRIMAG MOTOR 102956Recalls & reported problems

Summary

The FDA's MAUDE database contains 591 adverse event reports that list this exact device (DI 07640135140078), received between Jun 22, 2018 and Sep 25, 2026 — classified as 4 deaths, 119 injuries, 468 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (202 reports).

2 FDA recall records name this device's identifier.

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 22, 2019Class ITerminated

   Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

   Z-0221-2020 · Root cause: Process change control · Recall details · FDA record ↗

2. Sep 5, 2018Class IITerminated

   Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

   Z-0103-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 591 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50892682 ↗
• MalfunctionSep 18, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826465 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763576 ↗
• MalfunctionAug 21, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376729 ↗
• MalfunctionJul 28, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058083 ↗
• MalfunctionJul 27, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045616 ↗
• MalfunctionJul 16, 2026Mechanical Problem; Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846933 ↗
• MalfunctionJun 19, 2026Electrical Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE CENTRIMAG STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563562 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN OUT OF BOX CENTRIMAG MOTOR WOULD NOT BE RECOGNIZED BY ANY OF THE CONSOLES. THREE CENTRIMAG CONSOLES WERE ATTEMPTED, AND AN ERROR CODE OF MOTOR DISCONNECT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720311 ↗
• MalfunctionMar 25, 2026Unintended System Motion

  IT WAS REPORTED THAT AFTER THE CENTRIMAG PUMP WAS INSERTED A TWITCHING OF THE PUMP WAS SEEN. IT WAS INDICATED THE SPEED WAS AT 0 DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690360 ↗
• MalfunctionMar 20, 2026Pumping Stopped

  IT WAS REPORTED THAT THE REVOLUTIONS STOPPED. THE CENTRIMAG WAS EXCHANGED. THE PATIENT'S CURRENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651969 ↗
• MalfunctionMar 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CENTRIMAG MOTOR WAS SENT TO THE CUSTOMER AND THEY TRIED TO EXCHANGE THE CENTRIMAG MOTOR ON (B)(6) 2026. THE CENTRIMAG CONSOLE EXPERIENCED A M5 ERROR MESSAGE, WHICH ALLUDED TO A CENTRIMAG PUMP ISSUE. THE CENTRIMAG CONSOLE WAS TURNED OFF AND TURNED BACK ON, WHICH CLEARED THE ALARM. AFTER THAT, THE CENTRIMAG CONSOLE RECEIVED A M2 PUMP NOT CONNECTED ALARM WHICH BLOCKED THE RPMS FROM BEING ADJUSTED SO THEY WOULD NOT INCREASE. THEN THE CUSTOMER CONNECTED ANOTHER CENTRIMAG PUMP HEAD TO THE CENTRIMAG CONSOLE AND DID NOT HAVE ANY ISSUES. THE CUSTOMER WAS UNSURE IF THE PINS WERE BENT INSIDE THE CENTRIMAG PUMP CONNECTION. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561138 ↗
• MalfunctionMar 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN S3 ALARM WAS REPORTED ON THE CENTRIMAG MAIN UNIT. IN ADDITION, BATTERY MAINTENANCE WAS UNABLE TO BE PERFORMED DESPITE TROUBLESHOOTING ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560057 ↗
• 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 EXCHANGED AS A PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551896 ↗
• 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 24524158 ↗
• 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 24524126 ↗
• MalfunctionMar 5, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PUMP WAS NOT SEATED PROPERLY IN THE MOTOR. THEY MOVED THE PUMP TO BACKUP MOTOR AND RESUMED SUPPORT. THE EVENT WAS RESOLVED BY SWITCHING THE PUMP TO A BACKUP MOTOR. NO PRODUCTS WERE EXCHANGED AND NO PRODUCTS ARE RETURNING TO ABBOTT. THE PUMP WORKED AS INTENDED ON THE PATIENT ONCE SEATED IN THE NEW PUMP AND IS STILL ACTIVE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520804 ↗
• MalfunctionFeb 23, 2026Infusion or Flow Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416264 ↗
• MalfunctionFeb 11, 2026Insufficient 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 24313854 ↗
• 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 24241429 ↗
• 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 24217952 ↗
• MalfunctionJan 27, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE CENTRIMAG CONSOLE DID NOT RECOGNIZE THE MOTOR. THE UNIT WAS RETURNED FOR REPAIR. NO ALARMS WERE REPORTED BY BIOMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191044 ↗
• MalfunctionJan 22, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A CUSTOMER COMPLAINED IN RELATION TO A FAULT WITH A CENTRIMAG BLOOD PUMP. THE PUMP WOULD NOT SEAT CORRECTLY WITHIN THE MOTOR DRIVE; IT WAS TRIED ON MULTIPLE DRIVES BY THE END USER AND WAS ALSO TESTED UPON RETURN TO THE DISTRIBUTOR WITH THE SAME ISSUE BEING OBSERVED. THE PUMP HAD NOT BEEN USED CLINICALLY AND WAS NOT ON A PATIENT AT THE TIME THE ISSUE WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148735 ↗
• MalfunctionJan 14, 2026Display or Visual Feedback Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE ISSUE WAS ISOLATED TO THE MOTOR ONLY. TROUBLESHOOTING WAS PERFORMED WITH 4 MOTORS AND THE OTHER 3 MOTORS TESTED JUST FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070060 ↗
• MalfunctionJan 7, 2026Insufficient Device Problem Information

  LOG FILES COULD NOT BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996709 ↗