AxiEM™ 9734887XOM (UDI 00763000588380)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000588380), received between May 23, 2022 and Jun 23, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 15, 2022Open, Classified

   Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.

   Z-1039-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE PLACED THE POINTER ON THE TIP OF THE NOSE AND IT INDICATED THAT THEY WERE INSIDE OF THE CRANIAL VAULT. THE ESTIMATED AMOUNT OF INACCURACY OBSERVED WAS 10 MM. ONCE THE INACCURACY WAS DISCOVERED, THE ACCURACY WAS RESTORED TWICE USING CHECKPOINTS TAKEN BEFORE THE START OF SURGERY. IT WAS NOTED THAT NAVIGATION WAS DISCONTINUED. TO CONTINUE WITH THE PROCEDURE, THE IMPLANT HAD TO BE REGISTERED SEVERAL TIMES IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602425 ↗
• MalfunctionNov 25, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE PATIENT TRACKER WAS PLUGGED INTO THE AXIEM BOX AND A GREEN LIGHT WAS SEEN, BUT THE TRACKER ICON WAS NOT VISIBLE ON SCREEN, AND NO SYSTEM RESPONSE WAS OBSERVED WHEN INSTRUMENTS WERE INTRODUCED TO THE DIVOT. THE TRACKER WAS PLUGGED INTO A DIFFERENT PORT OF THE AXIEM BOX, BUT THERE WAS NO IMPROVEMENT. A NEW PATIENT TRACKER WAS THEN OPENED AND THE SYSTEM RECOGNIZED IT AND IT PERFORMED AS USUAL/AS EXPECTED. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A TEN-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644773 ↗
• MalfunctionOct 23, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS POOR RECOGNITION OF THE TRACKER. THE EMITTER WAS NOT BEING RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368875 ↗
• MalfunctionJul 7, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE REGISTERED THE PATIENT, THEN THE SURGEON TRIED TO NAVIGATE HIS BLADE AND SUCTION, AND THE NON-INVASIVE PATIENT TRACKER (NIPT) WAS NOT RECOGNIZED BY THE SYSTEM. THE SITE UNPLUGGED AND PLUGGED EVERYTHING BACK IN AND RESTARTED THE ENTIRE SYSTEM AND NOTHING FIXED IT. THE TRACKER WAS REPLACED AND THEN IT WORKED. THERE WAS A LESS THAN ONE HOUR DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419923 ↗
• MalfunctionMar 27, 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 NON-INVASIVE PATIENT TRACKER (NIPT) WAS NOT BEING RECOGNIZED BY THE APPLICATION. AN INSTRUMENT TRACKER WAS PLUGGED IN AND THAT WORKED AS DESIGNED. THE SITE THEN SWAPPED THE NIPT AND THAT ONE WAS RECOGNIZED AND THE CASE WAS CONTINUED. THIS CAUSED LESS THAN AN HOUR DELAY, AND NO REPORTED IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713735 ↗
• MalfunctionJan 22, 2025Device Sensing Problem; Device Sensing Problem

  2023-MAR-24 (B)(4): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS NOT RECOGNIZING THE BALLOON INSTRUMENT. THEY HAD TWO BALLOONS OPEN AND BOTH WERE NOT WORKING. TECHNICAL SERVICES (TS) WAS TROUBLESHOOTING THEIR SECOND BALLOON INSTRUMENT. TROUBLESHOOTING WAS PERFORMED. THEY LOOKED AT THE 4 QUADRANTS TO CONFIRM THAT THE SIDE EMITTER WAS WORKING AND IT WAS GREEN AND CONNECTED. THE INSTRUMENT WAS A RED CIRCLE WHEN IN THE FIELD OF VIEW. THEY CHANGED BACK TO THE FIRST BALLOON AND IT WAS GREEN. AT THAT POINT BOTH INSTRUMENTS WERE PLUGGED INTO THE MACHINE. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208493 ↗
• MalfunctionDec 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NON-INVASIVE PATIENT TRACKER (NIPT) WAS NOT RECOGNIZED EVEN WHEN IT WAS INSERTED INTO THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20949685 ↗
• MalfunctionNov 25, 2024Device Sensing Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE PATIENT TRACKER WOULD NOT TURN GREEN IN THE ELECTROMAGNETIC LOCALIZATION BOX. THE SCREEN ALSO SAID THAT PORT 3 WAS FAULTED, A NEW TRACKER WAS USED AND THE PROCEDURE CONTINUED WITHOUT ANY ISSUES. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LIKELY CAUSE WAS A BAD INSTRUMENT AS IT DID NOT WORK IN ANY OF THE PORTS. ADDITIONAL INFORMATION WAS RECEIVED. ALL 6 PORTS WERE TRIED AND EACH ONE FAILED AND WOULD NOT TURN GREEN. A NEW PATIENT TRACKER WAS OPENED AND IT WORKED IMMEDIATELY, AND IN ALL 6 PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775486 ↗
• InjuryOct 21, 2024Mechanical Problem; Biocompatibility; Mechanical Problem; Biocompatibility

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS A SINUS SURGERY, ENDOSCOPIC, WITH IMAGING GUIDANCE, LEFT ENDOSCOPIC MAXILLARY SINUSOTOMY WITHOUT REMOVAL OF TISSUE, LEFT ENDOSCOPIC ANTERIOR ETHMOIDECTOMY, FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), WITH IMAGING GUIDANCE. THERE WAS NO REPORTED DELAY TO THE CASE. IT APPEARED THAT THE STICKY PART OF THE PATIENT TRACKER TOOK THE VERY TOP LAYER OF SKIN OFF THE PATIENT, LEAVING A RED MARK. THERE WAS NO BLEEDING NOTED. THE PATIENT DID HAVE THIN PAPERY SKIN TO BEGIN WITH ACCORDING TO THE MANUFACTURE REPRESENTATIVE.

  Patient problems: Erythema

  MAUDE report 20491412 ↗
• MalfunctionAug 2, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO RESPONSE EVEN WHEN CONNECTED TO THE NAVIGATION SYSTEM. A SEPARATE INVENTORY WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892123 ↗
• MalfunctionJan 17, 2024Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING REGISTRATION THEY HAD REGISTRATION ISSUES. IT WAS NOT RECOGNIZING THE INSTRUMENTS. THE SITE TRIED TWO DIFFERENT PATIENT TRACKERS. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531703 ↗
• MalfunctionJan 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT THIS SYSTEM WAS UNABLE TO VERIFY THE REGISTRATION PROBE DURING A CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF 5-10 MINUTES. THE PROCEDURE WAS COMPLETED BY SWITCHING TO DIFFERENT TRACKERS AND WERE ABLE TO VERIFY THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531420 ↗
• MalfunctionJan 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT THIS SYSTEM WAS UNABLE TO VERIFY THE REGISTRATION PROBE DURING A CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF 5-10 MINUTES. THE PROCEDURE WAS COMPLETED BY SWITCHING TO DIFFERENT TRACKERS AND WERE ABLE TO VERIFY THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531391 ↗
• MalfunctionMar 16, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE TRACKER'S SIGNAL WAS UNSTABLE. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555580 ↗
• MalfunctionJan 13, 2023Device Sensing Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Application Program Freezes or Fails to Launch

  EVENT PREVIOUSLY REPORTED IN REGULATORY REPORT:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157907 ↗
• MalfunctionJan 5, 2023Incorrect, Inadequate or Imprecise Result or Readings

  TRACKER WOULD NOT REGISTER INSTRUMENT WHEN PLACED IN DIVOT TO BEGIN TRACKING. WOULD ONLY REGISTER INSTRUMENT WHEN PLACED ABOVE DIVOT, MAKING TRACKING INACCURATE. IF THE INACCURATE TRACKING WERE USED PATIENT HARM WOULD HAVE POTENTIALLY TAKEN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 16102442 ↗
• MalfunctionMay 23, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE PATIENT WAS ABLE TO BE REGISTERED BY TRACE METHOD WITHOUT ANY ISSUES. ONCE THE INSTRUMENT TRACKER WAS MOVED TO THE STRAIGHT SUCTION, IT WAS VERIFIED IN THE DIVOT OF THE NON-INVASIVE PATIENT TRACKER WITHOUT ISSUE. HOWEVER; THE STRAIGHT SUCTION FAILED TO NAVIGATE WITHIN THE ELECTROMAGNETIC (EM) FIELD. THE DISPLAY WAS STATIC AND THE CROSSHAIRS REMAINED RED. NO EXCESS METAL WAS IDENTIFIED IN THE EM FIELD. THE POSITION OF THE SIDE EMITTER WAS BOTH CHECKED AND ADJUSTED TO A NEW POSITION BUT THAT WAS UNSUCCESSFUL. THE INSTRUMENT TRACKER WAS MOVED TO THE 70 DEGREE SUCTION AND WAS VERIFIED BUT THE SAME ISSUE WITH NO NAVIGATION AND RED CROSSHAIRS CONTINUED. ULTIMATELY, THE SURGEON MOVED ON WITH PERFORMING THE SURGERY WITHOUT NAVIGATION AFTER 10 MINUTES OF TRYING TO FIX THE PROBLEM. AFTER SPEAKING WITH THE NURSING STAFF WHO WERE IN THE OPERATING ROOM (OR) DURING THE SYSTEM ISSUE, IT WAS BELIEVED THAT THE PHYSICIAN DID NOT PROGRESS THE SOFTWARE TO THE 'NAVIGATION' SCREEN. IT WAS BELIEVED THAT THE SURGEON ATTEMPTED TO NAVIGATE WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470163 ↗