AxiEM™ 9735317Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000588441), received between Mar 14, 2023 and Feb 20, 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.

• MalfunctionFeb 20, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACER POINTER HAD AN ISSUE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN STATED THAT THE POINTER WAS NOT ACCURATELY TRACKING KNOWN LANDMARKS. PHYSICIAN WOULD PLACE THE POINTER AT THE TIP OF THE NOSE AND THE TRACKER WOULD SHOW IT WAS POINTING NOT AT THE TIP BUT RATHER HALLWAY UP THE NOSE. WHEN THE DEVICE WAS EXCHANGED FOR A NEW ONE THE ISSUE WAS RESOLVED, THIS LET US TO BELIEVE IT WAS JUST A BAD POINTER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425067 ↗
• MalfunctionFeb 10, 2025Application Program Problem; Device Sensing Problem; Application Program Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SITE WENT TO REGISTER THE PATIENT USING THE TRACER PROBE AND THEY RECEIVED A MESSAGE IN THE SOFTWARE STATING "INSTRUMENT NOT VERIFIED. HOLD INSTRUMENT TIP IN VERIFICATION DIVOT UNTIL AUDIBLE CONFIRMATION." THE SITE TRIED TO VERIFY THE INSTRUMENT, EVEN THOUGH IT ISN'T REQUIRED FOR DISPOSABLE INSTRUMENTS, AND IT WOULD NOT VERIFY. THEY SWAPPED OUT THE PROBE WITH THE NAVIGATION PROBE AND WERE ABLE TO CONTINUE WITH THE CASE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349656 ↗
• MalfunctionMar 14, 2023Imprecision; Human-Device Interface Problem; Imprecision; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TRACER PROBE WAS INACCURATE AFTER A GOOD REGISTRATION. THE SITE RE-REGISTERED A TOTAL OF EIGHT TIMES TO GET A PASSING REGISTRATION, BUT WHEN THE SURGEON USED THE PROBE TO VERIFY THE ACCURACY, IT DID NOT SHOW PRECISELY WHERE THE PROBE WAS PLACED. THE VARIANCE OF ACCURACY CHANGED BETWEEN EACH REGISTRATION. ON THE LAST REGISTRATION, THE REGISTRATION ERROR WAS 1.0 MM. THE NAVIGATION LOOKED TO BE APPROXIMATELY 4 MM OFF. THE ENTIRE HEAD EXCEPT THE BACK WAS CIRCLED IN GREEN, WHILE THE BACK OF THE HEAD WAS IN YELLOW. THE GEOMETRY ERROR OF THE TRACING PROBE WAS A CONSISTENT .4 MM DURING TRACKING. THE INSTRUMENTS AND FRAME WERE CONSISTENTLY TRACKING WITH NO FLICKERING IN THE TRACKING VIEW. THE MANUFACTURER REPRESENTATIVE SAID THAT THE SKIN QUALITY ON THE MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE PATIENT LOOKED GREAT. THE MRI WAS OBTAINED THE DAY BEFORE. NAVIGATION WAS ABORTED, AND THE SURGEON SAID T HEY DID NOT WISH TO OPEN ADDITIONAL PRODUCTS DUE TO BACKORDER. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF TWENTY MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538131 ↗