ADULT FLOW PROBE 3/8" X 3/32" 102957Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640135140139), received between Mar 31, 2021 and Apr 24, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT FLOWS WERE NOTED TO DROP BELOW THE SET ALARM PARAMETERS. THE CENTRIMAG SYSTEM DID NOT PRODUCE A "FLOW BELOW MINIMUM" AUDIO OR VISUAL ALARM. THE PATIENT WAS ASSESSED AND NOTED TO BE STABLE. THE FLOW PROBE WAS TESTED BY REMOVAL FROM THE CIRCUIT. THE "FLOW SIGNAL INTERRUPTED" ALARM WAS ACTIVATED. THE FLOW PROBE SENSITIVITY WAS SET TO "SENSITIVE". LOW FLOW LIMIT BRIEFLY RAISED ABOVE CURRENT FLOW TO TEST ALARM - THE "FLOW BELOW MINIMUM" ALARM WAS ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981567 ↗
• MalfunctionJan 28, 2025Failure to Interrogate; Device Difficult to Setup or Prepare; No Apparent Adverse Event; Failure to Interrogate; Device Difficult to Setup or Prepare; No Apparent Adverse Event

  ADDITIONAL INFORMATION STATED THAT THERE WAS NO ISSUE WITH FLOW PROBE SINCE THE IT WAS TRIED WITH ANOTHER CONSOLE, AND IT WAS REGISTERING THE FLOW. THERE WERE NO ADVERSE IMPACTS TO THIS EVENT AS IT WAS DISCOVERED DURING PRIMING PHASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255714 ↗
• 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: 3003306248-2024-02754 (CONSOLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513775 ↗
• MalfunctionFeb 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE IN THE INTENSIVE CARE UNIT (ICU) CONNECTED TO THE CENTRIMAG, IT STOPPED WITH AN S3 ALARM. IT WAS TURNED ON AND OFF AND IT WORKED, HOWEVER STAFF DID NOT WANT TO CONTINUE USING IT. IT WAS ALSO NOTED THAT THE FLOW PROBE GAVE AN ERROR WITH THE CONSOLE. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) (CENTRIMAG CONSOLE). RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) (CENTRIMAG MOTOR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722690 ↗
• DeathJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM SHOCK. IT WAS NOTED THAT THE PRODUCTS HAD THE POSSIBILITY TO BE CONTAMINATED WITH METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS. RELATED MANUFACTURER REFERENCE NUMBER: 3003752502-2023-02412 (OXYGENATOR) RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-08404 (CENTRIMAG CONSOLE) RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-08405 (CENTRIMAG MOTOR)

  Patient problems: Bacteremia; Bacterial Infection; Hemodynamic instability; Respiratory Acidosis; Shock

  MAUDE report 18456650 ↗
• MalfunctionSep 18, 2023Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  RELATED CONSOLE MFR #: 3003306248-2023-05071. RELATED MOTOR MFR #: 3003306248-2023-05072.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765750 ↗
• MalfunctionAug 9, 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 17486884 ↗
• MalfunctionMar 31, 2021Infusion or Flow Problem; Infusion or Flow Problem

  RELATED MFR #S: 3003306248-2021-01076, 3003306248-2021-01078. IT WAS REPORTED THAT THE CENTRIMAG CONSOLE DISPLAYED ERROR MESSAGES B4 AND F3. FLOW COULD NOT BE INCREASED WITH AN INCREASE IN THE RPM. THE CUSTOMER SWITCHED OUT THE CONSOLE, MOTOR, AND FLOW PROBE FOR THEIR BACKUPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598885 ↗