AxiEM™ 9734887XOM (UDI 00763000738426)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000738426), received between Mar 23, 2026 and Mar 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT NONE OF THE DISPOSABLES WERE WORKING AND THE SURGEON COULDN'T TRACE/TRACK INSTRUMENTS. THEY SWITCHED NAVIGATION SYSTEMS AND THEN TWO OF EACH INSTRUMENT AND PATIENT TRACKERS AND THEN THEY FINALLY GOT THE SYSTEM WORKING. IT WAS UNKNOWN IF THE PRODUCT WAS DAMAGED. THIS ISSUE CAUSED A 20 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THEY USED BOTH OF THEIR SYSTEMS AND TRIED MULTIPLE DIFFERENT TRACKERS. IT WAS LIKELY A MIX OF USER ERROR, POTENTIAL DISPOSABLE FAULTS AND EVENTUALLY THEY FOUND THE RIGHT COMBINATION OF PRODUCTS AND EVERYTHING BEGAN WORKING. REGARDING SEEING THE INSTRUMENTS IN THE TRACKING WINDOW: "WE COULD NOT GET THEM GREEN STATUS. THEY WERE RED STATUS BOTH THE INSTRUMENT AND PATIENT TRACKER. THE INSTRUMENT WOULD COME IN AND OUT, BUT IT WOULDN¿T CALIBRATE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663288 ↗
• MalfunctionMar 23, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT NONE OF THE DISPOSABLES WERE WORKING AND THE SURGEON COULDN'T TRACE/TRACK INSTRUMENTS. THEY SWITCHED NAVIGATION SYSTEMS AND THEN TWO OF EACH INSTRUMENT AND PATIENT TRACKERS AND THEN THEY FINALLY GOT THE SYSTEM WORKING. IT WAS UNKNOWN IF THE PRODUCT WAS DAMAGED. THIS ISSUE CAUSED A 20 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THEY USED BOTH OF THEIR SYSTEMS AND TRIED MULTIPLE DIFFERENT TRACKERS. IT WAS LIKELY A MIX OF USER ERROR, POTENTIAL DISPOSABLE FAULTS AND EVENTUALLY THEY FOUND THE RIGHT COMBINATION OF PRODUCTS AND EVERYTHING BEGAN WORKING. REGARDING SEEING THE INSTRUMENTS IN THE TRACKING WINDOW: "WE COULD NOT GET THEM GREEN STATUS. THEY WERE RED STATUS BOTH THE INSTRUMENT AND PATIENT TRACKER. THE INSTRUMENT WOULD COME IN AND OUT, BUT IT WOULDN¿T CALIBRATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663256 ↗