AxiEM™ 9734887Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000588373), received between May 10, 2024 and Mar 5, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TRACKERS WERE NOT TRACKING AND HAD A GEOMETRY ERROR OF >1 MM. AFTER VERIFYING THE STRAIGHT SUCTION, THEY WENT TO VERIFY THE CURVED SUCTIONS AND ALL 3 INSTRUMENT TRACKERS SHOWED AS RED IN THE TRACKING DETAILS AND THE ONLY THING THAT WAS GREEN WAS THE NON-INVASIVE PATIENT TRACKER (NIPT), WHICH HAD A GEOMETRY ERROR OF 0.8MM. PORTS ON THE BREAK OUT BOX (BOB) WERE GREEN EXCEPT FOR PORT 4, WHICH DID NOT HAVE AN LED WHEN AN INSTRUMENT TRACKER WAS PLUGGED INTO IT; THEY TAPPED THE BOB AND IT TURNED GREEN AFTER THAT. THEY REPORTED THERE WAS NO METAL IN FIELD AND THERE WAS A 3 INCH PAD BETWEEN THE PATIENT AND THE BED. IT WAS NOTED THAT THE "EM FIELD SEEMED SMALLER THAN USUAL" AND REPORTED THE TRACKING ISSUES WOULD OCCUR WHEN THEY WERE ABOUT 12 INCHES ABOVE THE FLAT EMITTER. THEY REBOOTED THE SYSTEM AND REMOVED THE DONUT FROM UNDER THE PATIENT AND THE INSTRUMENTS SHOWED UP IN THE T RACKING WINDOW, THE INSTRUMENT TRACKERS AND NIPT GEOMETRY ERROR DROPPED TO 0.6 MM, BUT THE INSTRUMENT TRACKERS WOULD FLICKER RED WHEN THEY REACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526578 ↗
• MalfunctionJul 25, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM IN USE DURING A CRANIOTOMY STEREOTACTIC VENTRICULOPERITONEAL, RIGHT OCCIPITAL PERITONEAL SHUNT REVISION. IT WAS REPORTED THAT THE NON-INVASIVE PATIENT TRACKER DID NOT ORIGINALLY WORK WHEN PLUGGED INTO THE STEALTH MACHINE. WHEN IT WAS UNPLUGGED AND RE-PLUGGED BACK IN IT WORKED. MIDWAY THROUGH THE PROCEDURE, THE TRACKER STOPPED WORKING AND WOULD NOT RESTART. NO KNOWN HARM TO PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828684 ↗
• MalfunctionMay 10, 2024

  MIDDLE-AGED FEMALE WITH HISTORY OF PSEUDOTUMOR CEREBRI. PROCEDURE: CRANIOTOMY STEREOTACTIC VENTRICULOPERITONEAL, RIGHT OCCIPITAL PERITONEAL SHUNT REVISION. THE MEDTRONIC NAVIGATION NON-INVASIVE PATIENT TRACKER DID NOT ORIGINALLY WORK WHEN PLUGGED INTO THE STEALTH MACHINE. WHEN IT WAS UNPLUGGED AND RE-PLUGGED BACK IN IT WORKED. MIDWAY THROUGH THE PROCEDURE, THE TRACKER STOPPED WORKING AND WOULD NOT RESTART. NO KNOWN HARM TO PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285285 ↗