EM-TEC ADULT FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE 201-30105Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07640135140108), received between Jan 7, 2019 and Nov 13, 2025 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE FLOW HAD TO BE SET "QUITE HIGH" IN ORDER TO GET IT TO FLOW AT ALL, THEN COME BACK DOWN A BIT. A FEW HOURS LATER IN CARDIOVASCULAR, FLOWS WERE LOST AGAIN AND HAD TO SWITCH TO ANOTHER CIRCUIT. THERE WAS SOME CLOTTING IN THE VENOUS CANNULA. THE CUSTOMER REPORTED CONCERN REGARDING THE FLOW PROBE, ALTHOUGH UNLIKELY AS IT WAS NOTED THERE WAS ALSO A CORRELATION BETWEEN HEMODYNAMICS AND THE EVENT. THE CENTRIMAG CONSOLE WAS EXCHANGED.

  Patient problems: Hemodynamic instability; Thrombosis/Thrombus

  MAUDE report 23547839 ↗
• MalfunctionApr 8, 2025Electrical /Electronic Property Problem; Infusion or Flow Problem; Electrical /Electronic Property Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WAS ON A RENTED CMAG MOTOR, AND A REPLACEMENT WAS REQUESTED. THERE WAS A BEDSIDE EMERGENCY ON A NEW EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PATIENT. THE BEDSIDE ECMO SPECIALIST CALLED AND REPORTED THAT THE CENTRIMAG MOTOR WAS MAKING A STRANGE NOISE, AND THE PATIENT'S FLOWS HAD DROPPED FROM 5 LITERS PER MINUTE (LPM) TO 1.3 LPM. THE ECMO SPECIALIST REMOVED THE PUMP HEAD FROM THE PRIMARY MOTOR, AND BEGUN RESEATING THE PUMP HEAD IN THE BACKUP MOTOR. ONCE IN PLACE IN THE BACKUP MOTOR, FLOWS RETURNED TO 5 LPM AND THE PATIENT'S OXYGEN SATURATION AND MEAN ARTERIAL PRESSURES (MAPS) NORMALIZED. THE PATIENT REMAINED IN SINUS RHYTHM THROUGHOUT THE ENTIRETY OF THE INCIDENT. THE MOTOR, CONSOLE, AND FLOW PROBE IN USE WERE SEQUESTERED. USING A PRACTICE CIRCUIT, THE INCIDENT WAS ATTEMPTED TO BE REPLICATED, BUT ALL THE EQUIPMENT WAS FUNCTIONING APPROPRIATELY. THE MOTOR, CONSOLE, AND FLOW PROBE WERE REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21800255 ↗
• MalfunctionMar 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE FLOW SENSOR OF THE EXTRACORPOREAL BLOOD PUMPING SYSTEM FAILED AFTER THE TUBE POSITION WAS EXCHANGED. THE SENSOR DID NOT PRESENT ANY ALARM. THE SENSOR WAS REPLACED AND THE EVENT RESOLVED. THE EXCHANGED SENSOR WAS DECIDED TO BE DESTROYED LOCALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552364 ↗
• MalfunctionJan 10, 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 21127437 ↗
• MalfunctionAug 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CONSOLE HAD AN S3 ALARM. IT WAS NOTED THAT A PATIENT WAS ON THE SYSTEM FOR A BRIEF TIME. THE CONSOLE WAS RESTARTED BUT IT STILL HAD THE ALARM ACTIVE. THE PATIENT WAS MOVED TO A BACKUP SYSTEM WITH NEW CONSOLE, MOTOR, AND FLOW PROBE. THE NEW PRODUCTS WORKED AS EXPECTED AND THE PATIENT HAD NO SYMPTOMS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043660 ↗
• MalfunctionJul 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A MALFUNCTION OF THE FLOW PROBE WAS SUSPECTED, AND MEASUREMENT WAS NOT PERFORMED DUE TO MALFUNCTION. A REPAIR WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19854460 ↗
• MalfunctionJun 11, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS ADDITIONALLY REPORTED THAT THE CLINICIAN STATED THAT THE CENTRIMAG ALARMED WITH A FASTER PACED ALARM THAN USUAL. THERE WERE NO INTERVENTIONS BEING PERFORMED WITH THE PATIENT OR EQUIPMENT AT THE TIME OF THE SPONTANEOUS ALARM AND RPMS STOPPING. THE PHYSICIAN REPORTED SEEING A FLOW BELOW MINIMUM ALERT ON THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516121 ↗
• MalfunctionJan 29, 2024Calibration Problem; Infusion or Flow Problem; Calibration Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CENTRIMAG PATIENT WAS GETTING A COMPUTED TOMOGRAPHY (CT) SCAN AND AFTER MOVING BACK ONTO THEIR BED, THE FLOW ON THE CENTRIMAG CONSOLE WAS NOT READING A NUMERICAL FLOW, JUST THREE DASHES. THE CIRCUIT WAS EXAMINED FOR KINKS, BUT NO OBVIOUS KINKS WERE FOUND. BLOOD FLOW WAS CONFIRMED BY SHINING A LIGHT ON THE TUBING AND CHECKING THE MOTOR/PUMP HEAD FOR BLOOD FLOW MOVEMENT, WHICH CONFIRMED THAT THERE WAS BLOOD FLOW. THE FLOW SENSOR WAS VERIFIED TO BE POSITIONED PROPERLY AND FULLY CLOSED. FLOW PROBE CONNECTION TO THE CONSOLE WAS VERIFIED TO BE TIGHTLY INSERTED IN THE CENTRIMAG. DESPITE THESE STEPS, NO NUMERICAL FLOW READING WAS ACHIEVED. THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) HAD DECREASED FROM 66 TO 58 AND WAS HOLDING STEADY AT ~50MMHG, BUT THEY HAD ALSO RECEIVED A PROPOFOL BOLUS FOR MOVING ON THE CT TABLE, AND IT WAS NOT DECREASING. AN ADDITIONAL SPECIALIST EVALUATED THE SITUATION AND WAS CONCERNED ABOUT A FLOW PROBE MALFUNCTION. THE PUMP HEAD THEN INTERMITTENTLY MADE A LOUD VIBRATORY NOISE. IT WAS THOUGHT THAT POSSIBLY IT WASN'T SEATED PROPERLY, SO THE SPECIALISTS VERIFIED THAT THE PUMP HEAD WAS "SEATED" CORRECTLY IN THE MOTOR. THE NOISE FROM THE PUMP HEAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596359 ↗
• MalfunctionJan 23, 2024Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE NURSE OBSERVED A LOW FLOW ALARM WHILE THE PATIENT WAS ON CENTRIMAG (CMAG) SUPPORT IN THE INTENSIVE CARE UNIT. THE NURSE LOWERED THE RPMS TO ASSESS THE SITUATION. THE NURSE CLAIMED THAT A "PUMP FAILURE" ERROR WAS OBSERVED WHEN RPMS WERE ATTEMPTED TO BE RAISED BACK TO THE TARGET FLOW. THE PATIENT WAS SWITCHED TO THE BACKUP CONSOLE, MOTOR, AND FLOW PROBE. RELATED MANUFACTURER REFERENCE NUMBER FOR THE CENTRIMAG PRIMARY CONSOLE: MFR # 3003306248-2024-00005. RELATED MANUFACTURER REFERENCE NUMBER FOR THE CENTRIMAG MOTOR: MFR # 3003306248-2024-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563557 ↗
• MalfunctionOct 23, 2023Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS ADDITIONALLY REPORTED THAT THE THROMBUS WAS IDENTIFIED IN THE PROTEK DUO CANNULA THAT WAS USED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987364 ↗
• MalfunctionAug 9, 2023Infusion or Flow Problem; Infusion or Flow Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3003306248-2023-05049 AND 3003306248-2023-05048 IT WAS REPORTED THAT A CENTRIMAG MOTOR FAILED WHEN IN USE ON A PATIENT. THE FLOW WAS NOT REGISTERING AND ALARMED FOR NO FLOW. THE MOTOR WAS EXCHANGED, AS WELL AS THE CONSOLE, AND FLOW PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494168 ↗
• MalfunctionJul 31, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN EQUIPMENT FAILURE DURING CENTRIMAG IMPLANT. THE CONSOLE ALARMED INDICATING THAT THE MOTOR WAS DISCONNECT AND WITH FLOW ALARMS. THE MOTOR AND CONSOLE WERE SWITCHED TO BACKUP AND THE EQUIPMENT RESUMED NORMAL OPERATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431005 ↗
• MalfunctionJul 21, 2023Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CENTRIMAG WAS SUPPORTING THE PATIENT AND UNEXPECTANTLY CUT OUT AND ALARMED FOR ZERO FLOW, THE PATIENT WENT INTO CARDIAC ARREST. THE DEVICE WAS TURNED OFF AND WAS EXCHANGED OUT FOR A NEW ONE. THE MOTOR WAS ALSO EXCHANGED. THE FLOW PROBE ALSO RETURNED FOR EVALUATION. RELATED MANUFACTURER REPORT NUMBER: 3003306248-2023-01956 AND 3003306248-2023-01955.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374712 ↗
• MalfunctionJul 12, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE PATIENT HAD A SUSTAINED FLOW BELOW THE 0.7 LPM MIN FLOW ALERT LIMIT THAT DID NOT SHOW AUDIO OR VISUAL ALARM. BEFORE AND AFTER THIS EVENT, IT APPEARED THAT THE MINIMUM FLOW AND FLOW INTERRUPTED ALARMS OPERATED AS EXPECTED FROM THE DATA LOGGER FINDINGS. IT WAS COMMUNICATED THAT A STAFF MEMBER SWITCHED THE FLOW SENSITIVITY TO SENSITIVE PRIOR TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312159 ↗
• MalfunctionJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PREPARATION OF THE CENTRIMAG SYSTEM, WHEN THE CONSOLE WAS SWITCHED ON ALL INTERNAL TESTS RAN WITHOUT ISSUES AND THE CONSOLE WAS IN READY MODE. WHEN THE PUMP WAS INSERTED FOR THE DEAIRING PHASE OF CIRCUIT PREPARATION, THE PUMP DID NOT START AND A M4 WAS INITIATED. THE PRIMARY CONSOLE WAS RESTARTED, BUT THE ALARM CONTINUED. THE UNIT WAS REMOVED AND THE BACKUP WAS USED. CONSOLE MFR #: 3003306248-2023-01943. MOTOR MFR #: 3003306248-2023-01944.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075145 ↗
• MalfunctionJan 9, 2023No Audible Alarm; Display or Visual Feedback Problem; Insufficient Device Problem Information; No Audible Alarm; Display or Visual Feedback Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS NO IMPACT OR HARM CAUSED TO PATIENT FROM FLOW PROBE MALFUNCTION. THE ISSUE WAS RECTIFIED WITH NEW FLOW PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16123129 ↗
• MalfunctionSep 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING BIVAD CENTRIMAG SUPPORT THE CENTRIMAG MAG MONITOR FLOW DISPLAY STOPPED DISPLAYING VALUES. SPEED WAS DISPLAYED AND BLOOD FLOW REMAINED TO THE PATIENT. BLOOD FLOW WAS CONFIRMED BY ATTACHING A SEPARATE NON-CMAG FLOW PROBE TO THE SYSTEM. THE CMAG FLOW PROBE WAS EXCHANGED WHICH THEN DISPLAYED DOWN ARROWS. THE SYSTEM RECEIVED S3 CODES. THE CONSOLE AND FLOW PROBES WERE REMOVED AND THE PATIENT WAS SWITCHED TO A BACKUP SYSTEM WITHOUT INCIDENT. CMAG CONSOLE MFR#: 3003306248-2022-12512 MOTOR MFR#: 2916596-2022-14112.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487142 ↗
• MalfunctionSep 20, 2022Mechanical Problem; Mechanical Problem

  THE RETURNED FLOW PROBE ARRIVED WITH A CUT TO ITS CABLE SHEATHING EXPOSING ITS INTERNAL WIRING AND WAS REMOVED FROM SERVICE. A REPLACEMENT FLOW PROBE WAS PROVIDED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456137 ↗
• MalfunctionJul 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE FLOW PROBE DID NOT WORK. THE FLOW PROBE WAS NOT MEASURING FLOW THROUGH THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT. NO FLOW ALARMS WERE ACTIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103907 ↗
• InjuryNov 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAD HEMODYNAMIC COMPROMISE. THE PATIENT NEEDED INOTROPIC AND VENTILATORY SUPPORT. THERE WAS NO DATA AVAILABLE ON MEDICATIONS. THE PATIENT HAD AN ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) DIAGNOSIS DUE TO COVID. THE PATIENT WAS RESCUED BY ANOTHER INSTITUTION. WHEN THE PATIENT ARRIVED AT THE CLINIC SUDDENLY THE MOTOR STOPPED AND THE CONSOLE DID NOT EMIT ANY ALARM/ALERT. THE MOTOR WAS IMMEDIATELY CHANGED, WHICH WORKED, BUT THE FLOW PROBE DID NOT REGISTER THE FLOW. THE FLOW PROBE WAS CHANGED, BUT IT STILL DID NOT REGISTER FLOW. THE CONSOLE WAS CHANGED AND IT WORKED WITHOUT A PROBLEM. THE SUPPORT WAS RE-ESTABLISHED. THE PATIENT WAS IN CRITICAL CARE FOR BASIC PATHOLOGY IN VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO). THE PATIENT WAS STABLE AFTER INOTROPIC AND VENTILATORY SUPPORT. RELATED MANUFACTURER REPORT NUMBER OF MOTOR: 3003306248-2021-05721. RELATED MANUFACTURER REPORT NUMBER OF CONSOLE: 3003306248-2021-05722.

  Patient problems: Insufficient Information

  MAUDE report 12876214 ↗
• MalfunctionJul 24, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FLOW PROBE WAS NOT WORKING WITH THE CENTRIMAG CONSOLE. IT WAS NOTED THAT A PRONG IN THE FLOW PROBE WAS BENT/MISSING. THIS RESULTED IN THE FLOW PROBE BEING UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222668 ↗
• MalfunctionMay 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT'S CONSOLE HAD A S3 ERROR ALARM WITH NO APPARENT CAUSE AND SIMULTANEOUS LOSS OF FLOW READING ON THE CONSOLE. THIS WAS ABOUT 40 MINUTES AFTER THE INITIATION OF VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO), DURING WHICH THERE WAS NO ISSUE THE ERROR CODE AND ALARMS WERE UNABLE TO BE RESOLVED. ECMO HAD TO BE TEMPORARILY CLAMPED OFF TO EXCHANGE THE PATIENT TO BACKUP CONSOLE. THE CONSOLE WITH ALARM CODE WAS SWITCHED OFF AND BACK ON LATER WHICH CLEARED THE ERROR CODE. THE PATIENT LOST 30 SECONDS OF ECMO SUPPORT DURING CONSOLE EXCHANGE AND THERE WAS A TEMPORARY DIP IN PATIENT SATURATION. RELATED MFRS # 3003306248-2021-01116, 3003306248-2021-01117.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827659 ↗
• MalfunctionMay 10, 2021Alarm Not Visible; Mechanical Problem; Alarm Not Visible; Mechanical Problem

  IT WAS REPORTED THAT THE CENTRIMAG CONSOLE FLOW PROBE STOPPED WORKING WITH NO ALARMS IN THE CONSOLE. THE FLOW PROBE WAS CHANGED OUT, AND THERE WERE NO MORE PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798258 ↗
• MalfunctionSep 11, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT ANOTHER ECMO CIRCUIT WAS ASSOCIATED WITH THIS EVENT. RELATED MFR REPORT NUMBER FOR CONSOLE: 2916596-2020-04412, RELATED MFR REPORT NUMBER FOR MOTOR: 2916596-2020-04413.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10520597 ↗
• InjuryJul 12, 2019Decreased Pump Speed; Pumping Stopped; Decreased Pump Speed; Pumping Stopped

  IT WAS REPORTED THAT AFTER APPROXIMATELY 45 MINUTES AFTER INITIATION ON VA ECMO, A LOW FLOW ALARM WAS TRIGGERED. WHEN HEALTHCARE PROVIDERS WE LOOKED AT THE SCREEN, IT SAID ¿NO FLOW¿. HEALTHCARE PROVIDERS EMERGENTLY DID A PUMP CHANGE AND RESTORED THE REVOLUTIONS PER MINUTE(RPM) AND FLOW MEASURED IN LITERS PER MINUTE(LPM) BACK TO WHAT THEY WERE BEFORE THE NO FLOW ALERT OCCURRED. HEALTHCARE PROVIDERS WEREN¿T AWARE OF ANYTHING THAT HAPPENED THAT WOULD CAUSE THAT SUDDEN FAILURE IN FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8786383 ↗