Mag Monitor Set 201-90404Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640135140696), received between Sep 3, 2020 and Sep 11, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Pumping Stopped; Pumping Stopped

  RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-05059 (CENTRIMAG MOTOR). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-05060 (CENTRIMAG MOTOR). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-05074 (CONSOLE). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2023-05075 (CONSOLE). IT WAS REPORTED THAT WHILE SUPPORTING A BIVENTRICULAR ASSIST DEVICE (BIVAD) PATIENT IN THE OPERATING ROOM (OR), THE PATIENT EXPERIENCED SIMULTANEOUS PUMP STOPPAGES AS BOTH CENTRIMAG CONSOLES WENT TO ZERO RPM AND ZERO FLOW. SEVERAL SUCCESSIVE BEEPS SOUNDED, AND IT WAS NOTED THAT THE BEEPS SOUNDED LIKE THE EMERGENCY STOP BUTTON HAD BEEN PUSHED, ALTHOUGH NO ONE HAD DONE SO. THE RPMS OF BOTH SYSTEMS WERE MANUALLY INCREASED IMMEDIATELY, AND FLOW WAS RE-ESTABLISHED TO THE PATIENT. BOTH CONSOLES WERE ATTACHED TO CENTRIMAG MAG MONITOR AT THE TIME OF THE EVENT. IT WAS NOTED THAT POWER STRIPS, STRONG MAGNETS, CELL PHONES, FLUOROSCOPES, AND BLUETOOTH DEVICES WERE NOT USED IN CLOSE PROXIMITY AND THAT BOTH CONSOLES WERE PLUGGED INTO A RED EMERGENCY HOSPITAL AC POWER OUTLET. IT WAS ADVISED THAT THE MAG MONITOR BE DISCONNECTED FROM BOTH CONSOLES SO THAT THE CONSOLES COULD BE INTERFACED DIRECTLY, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725647 ↗
• MalfunctionMay 31, 2022Mechanical Problem; Infusion or Flow Problem; No Apparent Adverse Event; Mechanical Problem; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT WHEN THE PERFUSIONIST WAS TRYING TO DECREASE THE SPEED ON THE CENTRIMAG, THEY NOTICED THAT THE SPEED WAS SET TO ZERO AND WHEN THE SPEED WAS INCREASED, IT STOPPED AGAIN. THE MOTOR AND CONSOLE WERE SWITCHED TO THE BACKUP BUT THE SPEED WAS STILL UNABLE TO HOLD. A CLOT WAS THOUGHT TO BE IN THE CIRCUIT SO THE BLOOD PUMP CIRCUIT WAS EXCHANGED. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE EXCHANGED MOTOR: 3003306248-2022-10696. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE EXCHANGED CONSOLE: 3003306248-2022-10695.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 14548804 ↗
• MalfunctionJul 19, 2021Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  IT WAS REPORTED THAT THE CENTRIMAG MONITOR FROZE IN THE MANAGEMENT LOADING APPLICATION SCREEN DURING MANDATORY MONITOR UPGRADE. THE CONSOLE AND MONITOR WERE REBOOTED AND UNPLUGGED SEVERAL TIMES WITH SEVERAL MINUTES BETWEEN POWERING DOWN AND RESTARTING. THE MONITOR REMAINED LOCKED IN THE SAME LOADING SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188767 ↗
• MalfunctionSep 3, 2020No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  THERE WAS A MAG MONITOR THAT HAD A WHITE SCREEN WHEN CONNECTED. THE MONITOR WAS SENT IN FOR REPAIR, A LOANER WAS NOT REQUESTED AT THE TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10487858 ↗