AxiEMRecalls & reported problems across all models

We found 12 models of AxiEM by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and Jun 23, 2026 — classified as 1 injury, 61 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (50 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AxiEM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 ↗

2. Sep 26, 2018Terminated

   An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

   Z-0552-2019 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported AxiEM problems

AxiEM models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AxiEM™ 9734887XOM

  Neurological stereotaxic Instrument
  1 recall17 reports
• AXIEM™ 9733300

  Neurological stereotaxic Instrument
  1 recall0 reports
• AXIEM™ 9731975

  Neurological stereotaxic Instrument
  1 recall0 reports
• AxiEM™ 9733533XOM

  Neurological stereotaxic Instrument
  24 reports
• AxiEM™ 9735428

  Neurological stereotaxic Instrument
  8 reports
• AxiEM™ 9734887

  Neurological stereotaxic Instrument
  3 reports
• AxiEM™ 9735317

  Neurological stereotaxic Instrument
  3 reports
• AxiEM™ 9733605

  Neurological stereotaxic Instrument
  2 reports
• AxiEM™ 9734887XOM

  Neurological stereotaxic Instrument
  2 reports
• AxiEM 9733367

  Neurological stereotaxic Instrument
  1 report
• AxiEM™ 9733534XOM

  Neurological stereotaxic Instrument
  1 report
• AxiEM™ 9735016

  Ear, Nose, and Throat Stereotaxic Instrument
  1 report

Recent AxiEM adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 24663278 ↗
• 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. ADDITIONAL INFORMATION WAS RECEIVED. 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 24663265 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 16, 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 UPON TRYING TO REGISTER THAT PATIENT, THE SYSTEM WAS UNABLE TO TRACK. THE REGISTRATION PROBE WAS NOT SEEN ON THE SYSTEM, THEY TRIED MULTIPLE PORTS ON THE BREAK OUT BOX (BOB) WITH THE SAME OUTCOME. THEY SWITCHED TO NEW CABLE AND CONTINUED WITH THE PROCEDURE. THERE WAS A 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 22035114 ↗
• MalfunctionMay 2, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE STYLET WAS INTERMITTENTLY TRACKING. IT WAS BELIEVED TO BE AN OUT OF BOX FAILURE. TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (CS) RESEATED CONNECTIONS FOR THE BREAK OUT BOX (BOB) AND STYLET WITH NO RESOLUTION. THE CS MOVED THE SIDE EMITTER UP AWAY FROM THE PATIENT AND TRIED TO TRACK WITH NO RESOLUTION. THEY OPENED A NEW STYLET AND THE ISSUE RESOLVED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955110 ↗
• 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 ↗
• MalfunctionMar 11, 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 TRACKER WOULD NOT WORK DURING THE PROCEDURE. THEY IMMEDIATELY SWITCHED IT OUT WITH A NEW TRACKER AND IT WORKED FINE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND THERE WAS NO SURGICAL DELAY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576737 ↗
• 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 21526757 ↗
• 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 21526602 ↗
• 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 ↗

Other Medtronic Navigation, Inc. products

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