CentriMag™ 201-30500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640135140153), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Shutdown” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT ON (B)(6) 2021 THE CENTRIMAG MONITOR WAS HOOKED UP IN THE INTENSIVE CARE UNIT (ICU) TO THE PRIMARY AND THE BACKUP CONSOLE. OVER THE SPAN OF FIFTEEN MINUTES THE PUMP RANDOMLY STOPPED ABOUT FIVE TIMES. THE BOX WOULD POP UP ON THE SCREEN AND IT WOULD BEGIN THE COUNTDOWN TO PUMP OFF THAT TYPICALLY HAPPENS WHEN PRESSING AND HOLDING THE STOP BUTTON. THE MONITOR WAS DISCONNECTED AND THERE WERE NO CONSOLE ISSUES. EACH TIME THE PUMP OFF OCCURRED IT WAS ABLE TO BE RESTARTED WITHOUT ANY DELAY. THE MONITOR WAS HOOKED UP AGAIN AND AFTER A SHORT PERIOD OF TIME IT BEEPED AND STARTED THE PUMP OFF SEQUENCE AGAIN. THE MONITOR CABLE WAS REMOVED IMMEDIATELY AND THE PUMP DID NOT SHUT OFF THE LAST TIME. BOTH CABLES WERE REMOVED FROM THE MONITOR CART AND ON (B)(6) 2021 THE EVENT WAS ABLE TO BE REPLICATED THREE TIMES IN THE PERFUSION OFFICE. THE CORDS WERE INSPECTED FOR ANY OBVIOUS ISSUES, AND NOTHING NOTABLE WAS FOUND.

  Patient problems: Insufficient Information

  MAUDE report 12144435 ↗