FUSION CompactRecalls & reported problems across all models

We found 2 models of FUSION Compact by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Jan 8, 2026 — classified as 2 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 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 Compact problems

FUSION Compact models

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

• FUSION Compact ™ 9735602

  Ear, Nose, and Throat Stereotaxic Instrument
  64 reports
• FUSION Compact ™ 9735602R

  Ear, Nose, and Throat Stereotaxic Instrument
  4 reports

Recent FUSION Compact adverse event reports

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

• MalfunctionJan 8, 2026No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO REGISTER A PATIENT. THE SURGEON WAS UNABLE TO ACCURATELY REGISTER THE PATIENT. THE IMAGE BEING USED WAS ONLY 94 SLICES. THE SURGEON ATTEMPTED MULTIPLE REGISTRATIONS, BUT EACH ONE WAS FOUND TO BE INACCURATE ONCE IN THE VERIFY REGISTRATION. THIS ISSUE CAUSED AN UNKNOWN SURGICAL DELAY. THE IMPACT ON THE PATIENT'S OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003906 ↗
• MalfunctionNov 26, 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. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED. IT WAS CONFIRMED THE CD/DVD DRIVE OPENED, AND GREEN LIGHT WAS ON THE COMPACT. THE GREEN LIGHT ON THE POWER CORD BRICK WAS ON. THE SITE MOVED POWER OUTLETS WITH NO RESOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658951 ↗
• MalfunctionJul 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO LOAD AN EXAM VIA DISC. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383519 ↗
• MalfunctionApr 3, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WHERE THE UNIT OUT BOOT INTO A "LOCALIZER FAULTED" ERROR, REBOOTING WOULD RESOLVED THE ISSUE EACH TIME. THE SITE WAS GETTING IMPATIENT REGARDING THIS ISSUE AS IT WAS A DAILY OCCURRENCE. THE REPRESENTATIVE WAS UNABLE TO CHECK FOR THE LED NUMBER STATUS ON THE AXIEM BOX EACH TIME AS THE SITE REBOOTED THE UNIT RIGHT AWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763528 ↗
• MalfunctionMar 19, 2025Display or Visual Feedback Problem; Failure to Power Up; Power Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Failure to Power Up; Power Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM POWER BUTTON TURNED GREEN AND THE MEDTRONIC LOGO FLASHED ON THE SCREEN, BUT THEN THE SYSTEM WOULD SHUT OFF. THE SCREEN WOULD BLACK AND THE POWER BUTTON HAD NO LIGHTS. THE USER TRIED MULTIPLE REBOOTS AND DIFFERENT OUTLETS, BUT IT DID NOT RESOLVE THE ISSUE. A MEDTRONIC REPRESENTATIVE (REP) LATER CALLED FOR ADDITIONAL TROUBLESHOOTING. THE REP TESTED THE VOLTAGE ON SEVERAL POWER OUTLETS AND NOTED 120 VOLTS. THE REP ALSO SWAPPED SYSTEM POWER CABLES WITH A KNOWN WORKING NAVIGATION SYSTEM AND NOTED THAT THIS SYSTEM STILL WOULD NOT POWER ON, EVEN WITH A KNOWN WORKING POWER CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644132 ↗
• MalfunctionJan 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED INVERTED IMAGES EVERY TIME IT RECEIVED A DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) UPLOAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21059654 ↗
• MalfunctionSep 25, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO RECOGNIZE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807597 ↗
• MalfunctionJun 22, 2022Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT OCCASIONALLY, THE EMITTER DID NOT LIKE TO CONNECT AND TOOK SOME TROUBLESHOOTING TO GET IT TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14771892 ↗
• MalfunctionFeb 24, 2022Device Sensing Problem; Device Sensing Problem

  ON 2022-FEB-02 (B)(4) (REP, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE SITE WAS HAVING INTERMITTENT TRACKING DIFFICULTY DURING A CASE.  TROUBLESHOOTING STEPS WERE PERFORMED.  THE MANUFACTURER REPRESENTATIVE WALKED THE SITE THROUGH THE TRACKING DETAILS, ENSURING THAT NO METAL WAS IN THE FIELD.  THEY ALSO ADJUSTED THE EMITTER PLACEMENT, AND CHECKED THE STATUS OF THE EMITTER BOX.  IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS DUE TO A MALFUNCTIONING EMITTER.  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE TROUBLESHOOTING STEPS THAT WERE PERFORMED AT THE TIME OF THE EVENT WERE NOT ABLE TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE EMITTER WOULD BE RETURNED FOR ANALYSIS. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596219 ↗
• MalfunctionSep 17, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC LOCALIZATION SYSTEM COULD NOT CONNECT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487271 ↗
• MalfunctionJul 21, 2021Environmental Compatibility Problem; Application Program Freezes or Fails to Launch; Environmental Compatibility 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 THE SYSTEM HAD AN UNEXPECTED SHUT-DOWN, APPROXIMATELY TWENTY MINUTES AFTER BEING BOOTED UP. THE REP WAS ABLE TO REPLICATE THE ISSUE. PRIOR TO SHUTTING DOWN, SYSTEM WOULD DISPLAY, "COMMUNICATION ERROR". THERE WAS NO PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SYSTEM WAS PLUGGED INTO THE WALL WHEN IT SHUT DOWN. THE CAUSE OF THE COMMUNICATION ERROR WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202583 ↗
• MalfunctionApr 22, 2021Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED FOR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM IS NOT ACCURATE. THERE WAS NO HARM TO THE PATIENT PRESENT, AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11708263 ↗
• MalfunctionFeb 8, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE DOES NOT USE MARK LABEL TO REGISTER. IT WAS NOTED THAT THE LAST TIME THE SITE WAS CONTACTED, THEY USED IT NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294604 ↗
• MalfunctionFeb 8, 2021Connection Problem; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch; Connection Problem; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM FOR FUNCTIONAL ENDOSCOPIC SPINAL SURGERY (FESS). IT WAS REPORTED THAT THE SOFTWARE WAS SHOWING THAT THE LOCALIZER WAS DISCONNECTED ON (B)(6) 2021 AND THE AXIEM BOX WAS NOT COMMUNICATING. THE SITE POWERED OFF THE COMPACT AND BOOTED IT WITH THE AXIEM BOX POWERED ON AND THE COMMUNICATION CABLE BETWEEN THE COMPACT AND THE AXIEM BOX, WHICH RESOLVED THE ISSUE. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE WERE SETTING UP FOR A CASE WITH THE PATIENT IN THE ROOM AND THERE WAS ABOUT A 15 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294540 ↗
• MalfunctionDec 27, 2019Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED NO FURTHER ACTIONS WERE TAKEN. THE SYSTEM WAS NO LONGER UNDER A SERVICE AGREEMENT AND WOULD BE RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 9527269 ↗

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