N/A 9736242Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000336592), received between Apr 15, 2025 and Mar 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 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, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED A LOCALIZER FAULTED MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24538806 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SYSTEM WAS TRACKING WITH ~1 CM OF INACCURACY. THE SITE CONFIRMED THAT THE PATIENT IMAGE WAS CUTOFF AT THE TIP OF THE NOSE, SO THEY STARTED THEIR TRACE ABOVE THE CUTOFF POINT ON THE PATIENT, THE SYSTEM SHOWED "GREEN" AFTER REGISTRATION AROUND THE AREA THAT THE SURGEON WAS WORKING, THERE WAS NO METAL INTERFERENCE, AND THE FLAT EMITTER WAS BEING USED. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES (TS) GUIDED THE SITE THROUGH RE-REGISTERING THE TRACE, ADDING TOUCH POINTS, SUGGESTION OF CHECKPOINTS, AND SUGGESTION OF MODIFYING THE SCAN/MODEL. GIVEN THE IMAGE BEING CUTOFF ABOVE THE TIP OF THE NOSE, TS SUGGESTED DOING ONLY TOUCH POINTS TO REGISTER ON ANATOMICAL LANDMARKS THAT WERE PRESENT IN THE SCAN, THE SURGEON STATED HE WAS NOT INTERESTED AND PROCEEDED WITH CASE. IT IS UNKNOWN IF THERE WAS ANY IMPACT ON PATIENT OUTCOME OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178573 ↗
• MalfunctionJan 9, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE BLUE LIGHT ON THE POWER BUTTON INDICATED THE SYSTEM WAS ON, BUT THE SCREEN WAS BLANK. THE COMPACT DISC (CD) DRIVE WOULD OPEN AND CLOSE, BUT THE SCREEN REMAINED BLANK. THE SITE POWERED ON AND OFF SEVERAL TIMES WITH NO RESULTS. EVENTUALLY, AFTER ABOUT 30 MINUTES AND POWERING ON AND OFF 4-5 TIMES, THE SCREEN BEGAN TO REBOOT UP AND STARTED WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019198 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE OF INACCURACY WAS UNKNOWN BUT SIGNIFICANT ENOUGH THAT NAVIGATION WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803678 ↗
• MalfunctionSep 10, 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 SITE WAS ABLE TO REGISTER THE PATIENT WITH ACCURACY OF 1.0MM WITH TRACE AND TOUCH POINTS. HOWEVER, WHEN MOVING FORWARD TO BALLOON DILATION, THEY WERE UNABLE TO NAVIGATE THE BALLOONS. IT WAS NOTED THAT THERE WERE ISSUES TRACKING THE TWO BALLOONS. IT WAS SUSPECTED TO BE DUE TO ENVIRONMENTAL FACTORS. THERE WAS LESS THAN AN HOUR DELAY, AND NO REPORTED IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017445 ↗
• MalfunctionApr 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING NAVIGATION, WHEN THE INSTRUMENTS MOVED OUT OF THE ELECTROMAGNETIC FIELD, THE ENTIRE SCREEN, INCLUDING THE ONSCREEN BUTTONS WHEN BLACK. THE NAVIGATION PANEL WAS RESTORED ONLY WHEN AN INSTRUMENT WAS BROUGHT BACK INTO THE EM FIELD. THE ISSUE OCCURRED WITH ANY INSTRUMENT. THE SYSTEM WAS ON ITS FOURTH CASE OF THE DAY WITH NO REBOOTS IN BETWEEN. THERE WAS NO DELAY TO THE SURGERY AND NO ISSUES WITH ACCURACY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE ISSUE WAS RESOLVED WITH A REBOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21843474 ↗