CENTRIMAG PRIMARY CONSOLE 102954Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07640135140672), received between Aug 13, 2018 and Dec 18, 2025 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Complete Loss of Power; Unexpected Shutdown; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE CENTRIMAG CONSOLE COMPLETELY LOST POWER WHEN THE POWER CABLE WAS PULLED OUT FROM THE BACKUP CONSOLE. BOTH CONSOLES WERE CONNECTED TO THE SAME POWER STRIP. THE MOTOR SLOWED DOWN, AND THE PRESSURES DISAPPEARED AND NEEDED TO BE RECALIBRATED. THE EVENT LASTED FOR ABOUT A SECOND, BUT IT WAS POSSIBLE TO RAMP UP AGAIN AND GER THE FLOW GOING WITHOUT A RESTART. TROUBLESHOOTING WAS ONGOING AND THE PATIENT WAS BEING SUPPORTED BY THE SAME CONSOLE. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840205 ↗
• MalfunctionAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A S3 ALARM WHILE THE PATIENT WAS ON SUPPORT. THE CONSOLE AND MOTOR WERE EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842979 ↗
• MalfunctionJun 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CENTRIMAG MOTOR FAILED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167876 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN M4 "MOTOR ALARM" ON A CENTRIMAG MOTOR WHILE IT WAS BEING USED TO PRIME AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT. THERE WAS NO PATIENT ON THIS MOTOR AT THE TIME OF THE ALARM. THE CUSTOMER WAS ABLE TO USE THE MOTOR TO COMPLETE PRIMING OF THE CIRCUIT AND THEN REMOVED THE MOTOR FROM SERVICE BEFORE IT COULD HAVE BEEN PLACED ON A PATIENT. THE CUSTOMER STATED THAT THEY THINK THAT THIS PARTICULAR MOTOR HAD THIS ISSUE "A FEW YEARS AGO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561973 ↗
• MalfunctionJan 21, 2025Failure to Interrogate; No Apparent Adverse Event; Failure to Interrogate; No Apparent Adverse Event

  IT WAS REPORTED THAT CENTRIMAG MOTOR WOULD NOT CONNECT TO CENTRIMAG CONSOLE. M2 ALARM WAS PRESENT. THE UNIT WAS TAKEN OUT OF SERVICE AND REPLACED WITH A LOANER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198760 ↗
• MalfunctionJan 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE EVENT DID NOT HAPPEN WHILE ON A PATIENT. THE FAULTY CENSOR WAS DISCOVERED AS THE CUSTOMER WAS SPINNING A CIRCUIT TO GET READY TO CANNULATE A NEW PATIENT. AFTER IT WAS SWITCHED OUT IT WAS SENT TO THE SITES BIO-MED ENGINEER FOR EVALUATION WHO DETERMINED THE CENSOR WAS FAULTY. THERE WAS NO RECORD OF WHAT CONSOLE THE FLOW PROBE HAD COME OFF OF. LOG FILES WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118110 ↗
• MalfunctionNov 6, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING THE TECHNICAL INSPECTION FOR POSSIBLE RELEASE, IT WAS DETECTED THAT THE EQUIPMENT WAS DISCONTINUED EQUIPMENT. IT WAS TESTED ON THE POWER SUPPLY AND DID NOT TURN ON. THE PRODUCT WOULD BE SENT FOR DESTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619560 ↗
• MalfunctionOct 17, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT A CENTRIMAG MOTOR WOULD NOT BE RECOGNIZED BY CONSOLES. CONSOLES WOULD STATE "MOTOR DISCONNECTED" MESSAGE. UNIT WAS REQUESTED TO BE RETURNED FOR COMPLAINT INVESTIGATION AS TECHNICAL SERVICE CANNOT REPAIR MOTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474712 ↗
• MalfunctionSep 29, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS ADDITIONALLY REPORTED THAT THE PATIENT RETURNED FROM THE CATHETERIZATION LABORATORY AND THE CENTRIMAG CONSOLE AND CENTRIMAG MOTOR STOPPED FUNCTIONING. THERE WAS ZERO FLOW ON THE CENTRIMAG SCREEN, AND UPON PALPITATION OF THE MOTOR THERE WAS NO VIBRATION. THE CENTRIMAG HAD TO BE EMERGENTLY SWAPPED OUT TO A BACKUP CENTRIMAG TO GET THE PATIENT'S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT RUNNING. IT WAS CONFIRMED THAT EXCHANGING THE CONSOLE AND MOTOR RESOLVED THE ISSUE. IT WAS NOTED THAT THE EQUIPMENT SERVICE REPORT SENT TO THE CUSTOMER FROM ABBOTT NOTED THE ISSUE AS BEING WITH THE MOTOR AND THE CORD BEING FLEXED CAUSING THE M4 ERROR. THE MOTOR WAS DEEMED UNABLE TO BE REPAIRED AND WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330512 ↗
• MalfunctionSep 9, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CENTRIMAG CONSOLE SHOWED ZERO REVOLUTIONS PER MINUTE (RPM) WHILE ON A PATIENT. THE PATIENT WAS SWITCHED TO A BACKUP SYSTEM WITH NO ISSUES. NO PATIENT INFORMATION WAS AVAILABLE. THE CENTER WOULD LIKE TO SEND THE CENTRIMAG CONSOLE AND MOTOR FOR EVALUATION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171906 ↗
• MalfunctionAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER HAD AN M4 ALARM WHEN UTILIZING ONE OF THEIR CENTRIMAG MOTORS. THE MOTOR WAS REPLACED WITH A DIFFERENT ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050857 ↗
• MalfunctionJun 12, 2024Communication or Transmission Problem; Insufficient Device Problem Information; Communication or Transmission Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FLOW PROBE STOPPED READING FLOW ON A CENTRIMAG CONSOLE. A DIFFERENT FLOW PROBE WAS TRIED AND THAT DID NOT CORRECT THE PROBLEM. THE FLOW PROBES WERE TESTED ON ANOTHER CENTRIMAG CONSOLE, AND WORKED FINE. THE CENTRIMAG CONSOLE WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521962 ↗
• MalfunctionJun 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LOW FLOW ALARM WHILE USING CENTRIMAG, HOWEVER THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SPECIALIST NOTICED THE FLOW WAS STILL AT THE SET LEVEL. THEN THE REVOLUTIONS PER MINUTE (RPM) AND THE FLOW DROPPED TO ZERO. THE CONSOLE AND MOTOR WERE EXCHANGED WITH THE BACKUP CONSOLE AND MOTOR REPORTEDLY UNEVENTFULLY ALTHOUGH THE PATIENT'S BLOOD PRESSURE DID DIP DURING THE TIME OFF ECMO WITH NO ADVERSE PATIENT IMPACT. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-02752 (MOTOR) RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-02753 (FLOW PROBE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513720 ↗
• MalfunctionMay 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR WAS SENT BACK FOR EVALUATION BECAUSE THE CUSTOMER STATED THE MOTOR WAS STARTING TO HEAT UP. IT WAS STATED THAT THERE WAS PATIENT INVOLVEMENT, AND THAT THE PATIENT WAS SWITCHED FROM VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) TO A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) ON (B)(6) 2024. THE CENTRIMAG MOTOR WAS PULLED AND EXCHANGED PRIOR TO INITIATION OF RVAD. IT WAS UNKNOWN WHAT EVENTS LED UP TO THE MOTOR HEATING UP AS THE MOTOR WAS OLDER. THE SYSTEM PLUGS WERE CHECKED, THE CORD WAS CHECKED FOR EXPOSED WIRING, AND IT WAS STATED THEN THAT THE MOTOR WAS GETTING WARMER. THIS HAPPENED PRIOR TO THE PATIENT'S TRANSITION FROM VA-ECMO TO RVAD. NO ALARMS WERE NOTED BUT ABNORMAL TEMPERATURE TO THE TOUCH. AN ECMO SPECIALIST/PERFUSION/SURGEONS CONTINUED TO MONITOR THROUGHOUT UNTIL THERAPY CHANGE-VA ECMO TO RVAD. MOTORS WERE EXCHANGED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315593 ↗
• MalfunctionJan 30, 2024Pumping Stopped; Unexpected Shutdown; Pumping Stopped; Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP MOTOR WAS STOPPING. NO ADDITIONAL INFORMATION WAS PROVIDED. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00036.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605522 ↗
• MalfunctionJan 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT AS CANNULATED FOR VENOUS-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO). AN EMERGENT OXYGENATOR CHANGE WAS REQUIRED, AND THE CIRCUIT WAS SWITCHED TO THE CARDIOHELP AT 1844. A REPEAT ECHOCARDIOGRAM SHOWED WORSENING BI-VENTRICULAR FUNCTION, SO THE PATIENT WAS PLACED ON VENOARTERIAL-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VA-V ECMO). THE PATIENT'S BILATERAL LOWER EXTREMITIES (BLE) WERE MOTTLED, AND THEY WERE TAKEN TO THE CATHETERIZATION LAB FOR ANGIOGRAM OF BLE AND VASCULAR CONSULT. THERE WAS A CONCERN THAT THERE WAS SEVERE SPASM OF DISTAL VESSELS. THEY WERE TAKEN BACK TO THE INTENSIVE CARE UNIT (ICU) AND BECAME SEVERELY VASOPLEGIC AND WERE UNABLE TO MAINTAIN MEAN ARTERIAL PRESSURE OR ECMO FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456603 ↗
• MalfunctionOct 16, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT WHILE PRIMING THE CIRCUIT, THE CONSOLE WENT FROM 1500 TO 0 ROTATIONS PER MINUTE (RPM). THE CONSOLE RANDOMLY STOPPED FLOWING AND A LOW FLOW ALARM OCCURRED. IT WAS UNPLUGGED AND TURNED BACK ON. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-07173 (CENTRIMAG MOTOR MODEL #: 102956).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940474 ↗
• MalfunctionAug 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS ON CENTRIMAG SUPPORT. ON (B)(6)2023, THE CENTRIMAG ALARMED WHILE A NURSE WAS IN THE ROOM. THE NURSE NOTED DASHES ON THE FLOW PROBE READING, AT THAT TIME THEY HEARD A ¿SWISHING SOUND, OR A WATER THROUGH HOSE¿ SOUND COMING FROM THE PUMP, AT THE SAME TIME THE PATIENT BECAME SUDDENLY AGITATED, AS IF THE RESPONSE WAS TO SOMETHING PAINFUL. THE EVENT LASTED 15 SECONDS, AND THE FLOW READING RETURNED TO BASELINE WITHOUT INTERVENTION ON THE FLOW PROBE. NO CHANGES IN PATIENT ASSESSMENT OR MONITOR VITALS WERE NOTED. LOG FILES WERE OBTAINED, AND THE ENTIRE SYSTEM WAS CHANGED ON (B)(6)2023. THERE WERE NO ALARMS REPORTED DURING THIS EVENT. IT WAS LATER COMMUNICATED THAT THE PATIENT WAS STABLE AND WAITING FOR A HEART TRANSPLANT. THE CAUSE OF THE SWISHING SOUND WAS NOT DETERMINED. THE SOUND REPORTEDLY RESOLVED PRIOR TO THE EQUIPMENT BEING EXCHANGED AND ONLY LASTED ABOUT 15 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17473890 ↗
• InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 3003306248-2023-00758.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16526215 ↗
• MalfunctionJan 19, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN MOVING THE CENTRIMAG MOTOR FROM THE RETRIEVAL TROLLEY TO THE PATIENT'S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CART, THE SPEED REDUCED FROM 3800 ROTATIONS PER MINUTE (RPM) TO 0 RPM SPONTANEOUSLY. A MESSAGE APPEARED ON THE CONSOLE THAT SAID "? UNABLE TO ACHIEVE SET RPM". THE MOTOR WAS EXCHANGED. MOTOR MFR # 3003306248-2023-00001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206738 ↗
• MalfunctionDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WHILE IN THE OPERATING ROOM. JUST BEFORE TRANSFER TO THE INTENSIVE THERAPY UNIT (ITU), THE CART WAS UNPLUGGED FROM THE MAINS. THERE WAS AN IMMEDIATE S3 ERROR ON THE CONSOLE WHICH COULD NOT BE CLEARED. THERE WAS NO ISSUE OR CHANGE IN FLOW, BUT IT WAS DECIDED TO SWAP TO A NEW CONSOLE, MOTOR, AND FLOW PROBE. RELATED MANUFACTURER'S REPORT NUMBER FOR THE MOTOR: 3003306248-2022-14524.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017829 ↗
• MalfunctionNov 8, 2022Insufficient Device Problem Information; Unexpected Shutdown; Insufficient Device Problem Information; Unexpected Shutdown

  IT WAS REPORTED THAT THE CENTRIMAG (CMAG) STOPPED WHILE IT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND DISPLAYED MOTOR FAILURE ERROR MESSAGE. THE MOTOR AND BACKUP CONSOLE WERE SWITCHED OUT.

  Patient problems: Insufficient Information

  MAUDE report 15753238 ↗
• MalfunctionMar 14, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT THE CENTRIMAG MOTOR HAD ISSUES WITH CENTERING THE ROTOR. THE MOTOR WOULD NOT CONNECT PROPERLY TO THE CENTRIMAG CONSOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE ISSUE WAS NOT IDENTIFIED AND THE ISSUE DID NOT RESOLVE. THE MOTOR WAS REMOVED FROM USE AND RETURNED FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES. RELATED MFR. REPORT NUMBER: 3003306248-2022-00041.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759828 ↗
• MalfunctionMar 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE THE REVOLUTIONS ON THE CENTRIMAG MOTOR WENT UP, BUT THE MOTOR WAS NOT PUT INTO OPERATION. ADDITIONALLY, WHEN THE REVOLUTIONS WERE RAISED THE MOTOR WOULD NOT ROTATE AT ALL. AN M5 ALARM WAS NOTED AND THERE WAS ALSO A 'WHISTLING' NOISE. THE PERFUSIONIST CHANGED THE MOTOR WHICH RESOLVED THE ISSUE. THE PATIENT WAS IN STABLE CONDITION WITH THE UNIT ON. IT WAS NOTED THAT THERE WAS NOT SIGNIFICANT DELAY IN THE SURGERY. THE WHOLE SYSTEM WAS EXCHANGED. MANUFACTURER'S REPORT NUMBER OF THE MOTOR: 3003306248-2022-00016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13650396 ↗
• MalfunctionFeb 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS ON SUPPORT FOR EXTRA CORPOREAL MEMBRANE OXYGENATION. THE MOST RECENT CIRCUIT CHANGE WAS APPROXIMATELY 17 DAYS PRIOR TO THE EVENT. THE PATIENT HAD BEEN OFF OF ANTICOAGULATION THROUGHOUT ECMO COURSE DUE TO BLEEDING. THE PATIENT WAS NOT ON HEPARIN DRIP. ON (B)(6) 2022 THE PATIENT WAS AT 1100 AND THE MOTOR WAS REPORTED TO BE HOT TO THE TOUCH WITH NO ALARMS. THE TEAM SWITCHED TO FULL BACKUP BATTERY SYSTEM. ON (B)(6) 2022 THE MOTOR WAS STILL HOT BUT AS NOT AS HOT AS THE PREVIOUS. A PLAN WAS MADE TO NOT SWITCH ANYTHING AND TO CONTINUE TO MONITOR THE PATIENT. A LARGE CIRCUIT CHANGE WAS CONSIDERED BUT THE PATIENT WAS DEPENDENT ON ECMO. ROTATIONS PER MINUTE WERE AT 5300 ON THE CURRENT SYSTEM AND THE PREVIOUS ONE SWITCHED OUT. SPEEDS ON 5500 RPM WERE UNABLE TO BE OBTAINED. THE MOTOR WOULD BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506213 ↗