Fusion ENT Image Guidance SystemRecalls & reported problems across all models

We found 5 models of Fusion ENT Image Guidance System by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 2,033 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2016 and Sep 10, 2026 — classified as 32 injuries, 2,001 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (334 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. 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

Most reported Fusion ENT Image Guidance System problems

Fusion ENT Image Guidance System models

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

• Fusion™ ENT Image Guidance System 9733560XOM

  Neurological stereotaxic Instrument
  1,316 reports
• Fusion™ ENT Image Guidance System 9733560

  Neurological stereotaxic Instrument
  458 reports
• Fusion™ ENT Image Guidance System 9733560XOM

  Neurological stereotaxic Instrument
  188 reports
• Fusion™ ENT Image Guidance System 9733560XOMR

  Neurological stereotaxic Instrument
  66 reports
• Fusion™ ENT Image Guidance System 9733560

  Neurological stereotaxic Instrument
  5 reports

Recent Fusion ENT Image Guidance System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721602 ↗
• MalfunctionFeb 2, 2026Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN LOADING A PATIENT DISC, THE MANUFACTURER REPRESENTATIVE (REP) RECEIVED A DISC FORMAT ERROR. TROUBLESHOOTING STEPS WERE PERFORMED. THE REP HAD A NEW DISC BURNED WHICH HAD THE SAME FORMAT ERROR. THE REP STATED ONE DISC WAS UNCOMPRESSED DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) AND ONE WAS NOT BUT BOTH HAD THE SAME ERROR. THE EXAM SHOWED 0 SLICES, 0 THICKNESS, ETC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235801 ↗
• MalfunctionDec 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREEN WAS BLACK. THEY WERE ABLE TO TURN ON THE SYSTEM, BUT AS SOON AS THE UNIT BOOTED UP, THE SCREEN STAYED BLACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877089 ↗
• MalfunctionJul 15, 2025Display or Visual Feedback Problem; Application Program Problem; Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INTERMITTENT SYNC MESSAGE AND THEN THE SCREEN WOULD GO BLACK. THE POWER LIGHT EMITTING DIODE (LED) STAYED ILLUMINATED. IT WAS NOTED THAT REBOOTING DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507040 ↗
• MalfunctionJul 9, 2025Communication or Transmission Problem; Delayed Program or Algorithm Execution; Communication or Transmission Problem; Delayed Program or Algorithm Execution

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAS BEEN TAKING LONGER TO LOAD EXAMS AND THAT THE SOFTWARE "APPEARED SLOWER THAN USUAL". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462336 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BEFORE A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE, THE PATIENT DATA WAS NOT BEING READ WHEN A CD WAS INSERTED. RESTARTING THE SYSTEM MAY OCCASIONALLY RESTORE FUNCTIONALITY. ADDITIONALLY, THE SYSTEM SOMETIMES FROZE DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346242 ↗
• MalfunctionJun 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC LOCALIZATION SYSTEM/EMITTER (AXIEM¿) INTEGRATED 4-PORT SYSTEM WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214461 ↗
• MalfunctionJun 12, 2025Communication or Transmission Problem; Delayed Program or Algorithm Execution; Communication or Transmission Problem; Delayed Program or Algorithm Execution

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE SYSTEM WAS SLOW UPDATING RESULTS OF TESTS. PATIENT PRESENCE UNKNOWN. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED BEFORE PLANNING THE SURGERY WITH NO PATIENT PRESENT. THE SYSTEM HAD PROBLEMS READING PATIENT IMAGES FROM THE DISK. THE SITE WAS PREPARING FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE AND IT WAS ABLE TO BE COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195363 ↗
• MalfunctionMay 13, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN EXAM LOADING ISSUE ON THE SYSTEM. WHEN ATTEMPTING TO LOAD A PATIENT EXAM VIA CD, THE SYSTEM PROGRESSED TO 99% PROGRESS COMPLETION BEFORE STOPPING, AND AN ERROR MESSAGE INDICATED "NO SOURCE DATA." IT WAS LATER REPORTED THAT THE DISC WAS THE ROOT ISSUE. THE ISSUE WAS RESOLVED WHEN A NEW DISC WAS BURNED, ALLOWING THE EXAM TO LOAD SUCCESSFULLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013987 ↗
• MalfunctionApr 24, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE REPORTED ISSUE WAS INTERMITTENT TRACKING OF INSTRUMENTS. 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 21902773 ↗
• MalfunctionApr 1, 2025Application Program Problem; Device Sensing Problem; Application Program 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 INSTRUMENTS WERE NOT TRACKING. THE EMITTER DISPLAYED A 'LOW SIGNAL' WARNING. THE USER WAS ADVISED TO CHECK FOR POTENTIAL METAL INTERFERENCE, AND IT WAS DETERMINED THAT A MAYO STAND WAS POSITIONED NEXT TO THE EMITTER. REMOVING THE MAYO STAND IMPROVED INSTRUMENT TRACKING. DURING NAVIGATION, THE SURGEON REPORTED THAT THE STRAIGHT SUCTION INSTRUMENT WAS INTERMITTENTLY FLICKERING. THE USER REPOSITIONED THE EMITTER TO FIND THE OPTIMAL PLACEMENT FOR THIS PROCEDURE. RAISING THE EMITTER AND POSITIONING IT CLOSER TO THE PATIENT HELPED STABILIZE INSTRUMENT TRACKING. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740271 ↗
• MalfunctionMar 26, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE. IT WAS REPORTED THAT IN REGARDS TO THE SURGICAL PROCEDURE, THE PROCEDURE WAS NOT ABORTED AND IT WAS CARRIED OUT WITH NAVIGATIONAL GUIDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699624 ↗
• MalfunctionMar 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHENEVER THE SYSTEM TURNED ON THE UNIT PROVIDES INDICATION THAT IT WAS RECEIVING POWER FOR EXAMPLE THE SYSTEM FAN WAS ON, BUT THE MONITOR REMAINED BLACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662597 ↗
• MalfunctionFeb 11, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN LOADING THE PATIENT EXAM VIA COMPACT DISC (CD), THE SYSTEM DISPLAYED AN ERROR MESSAGE OF, "UNABLE TO INTERPRET HEADER DATA." SITE NOTED THAT THE SYSTEM DISPLAYED THE SAME MESSAGE ON STRUCTURED AND UNSTRUCTURED DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) WHEN LOADING. TROUBLESHOOTING INCLUDED HAVING SIDE LOAD THE CD ONTO A COMPUTER. SITE NOTED THERE WERE SEVERAL IMAGER VIEWING APPLICATIONS, AN AUTORUN FILE, AND A README IN THE EXAM. SITE UNABLE TO DELETE THESE FILES, AS THE DISC WAS READ ONLY. SITE TRANSFERRED THE DICOM FOLDER AND THE DICOMDIR FILE ONTO A FAT32 USB. THE SYSTEM RECOGNIZED THE FILE, BUT THEN DISPLAYED AN ERROR MESSAGE "NO SOURCE DATA FOUND." THE SITE WAS INSTRUCTED TO ALTER THE UNIVERSAL SERIAL BUS (USB) WITH SEVERAL FILE PERMUTATIONS. THE EXISTING FOLDER STRUCTURE WENT FROM DICOM TO PAT001 TO STUDY01 TO 400 DICOM FILES. THE STIE TRIED TO MOVE THE 400 DICOM FILES INTO THE PAT001 FOLDER, BUT THE ISSUE PERSISTED. SITE TRIED MOVING THE 400 DICOM FILES TO THE DICOM FOLDER, AND THE ISSUE PERSISTED. SITE NOTED THAT REBURNING A CD WAS NOT AN OP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356464 ↗
• MalfunctionFeb 7, 2025Device Sensing Problem; Human-Device Interface Problem; Device Sensing Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE EMITTER FIELD WAS "VERY SMALL" AND THE INSTRUMENTS WERE NOT TRACKING AS EXPECTED. THE REPRESENTATIVE ON SITE REPORTED THAT REGISTRATION WAS COMPLETED SUCCESSFULLY AND ACCURACY WAS VERIFIED. THEN MID-WAY THROUGH THE PROCEDURE WHEN SWITCHING TO THE 70 DEGREE CURVED SUCTION INSTRUMENT, THE REP REPORTED THAT THE SURGEON TOUCHED APPX. 4 CM AWAY FROM THE PATIENT TRACKER AND THE SYSTEM REGISTERED THAT THE BACK BUTTON HAD BEEN TOUCHED "SEVERAL TIMES". THE REP REPORTED THAT THIS CAUSED THE REGISTRATION TO BE "ERASED" AND THE SURGEON HAD TO RE-REGISTER THE PATIENT. THE PROCEDURE CONTINUED WITHOUT ANOTHER INCIDENT OF THIS NATURE, HOWEVER THE REP REPORTED THAT THROUGHOUT THE ENTIRE PROCEDURE THE EMITTER FIELD REMAINED "VERY SMALL". THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT THERE WERE NO EXTERIOR METAL IN THE FIELD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS LESS THAN 1 HOUR DELAY IN THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333694 ↗

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