FUSION Compact ™ 9735602RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000099787), received between Feb 24, 2022 and Apr 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗