N/A 9735016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169443518), received between Jul 1, 2024 and Apr 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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 18, 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 4, 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 PATIENT TRACKER AND INSTRUMENT TRACKER WERE OPERATING PERFECT WITH ALL INSTRUMENTS EXCEPT THE 70 DEGREE SUCKER WOULDN'T VERIFY. ONCE PLUGGED IN, THE MALLEABLE SUCTION WOULDN'T APPEAR ON THE NAVIGATION SCREEN AND DID NOT APPEAR IN THE TRACKER/EMITTER DETAILS (BOTTOM RIGHT CORNER OF SCREEN). MOVING THE MALLEABLE SUCTION ALL AROUND THE PATIENT HEAD, IT APPEARED BRIEFLY IN RED AT EXTREMITIES OF THE MAGNETIC FIELD PRODUCED BY THE SIDE EMITTER. THE MALLEABLE SUCTION WAS PLUGGED INTO OTHER AXIEM PORTS WITH SAME BEHAVIOR CONTINUING. THE MALLEABLE SUCTION WAS ABANDONED AND COMPETED THE CASE WITH A METAL INSTRUMENT SET. THIS ISSUE CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777915 ↗
• MalfunctionMar 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 MALLEABLE SUCTION WAS PLUGGED INTO AN ELECTROMAGNETIC NAVIGATION INTERFACE UNIT (AXIEM) PORT AND THE SYSTEM WAS UNABLE TO SEE SUCTION IN THE FIELD OF VIEW. A REPLACEMENT SUCTION WAS OPENED WITH NO ISSUE AND PROCEDURE CONTINUED. THERE WAS NO DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566363 ↗
• MalfunctionNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. THE SITE NURSES PLUGGED THE INSTRUMENT INTO THE NAVIGATION SYSTEM, IT REGISTERED AS IT SHOULD BUT WHEN THE SURGEON TRIED TO VERIFY THE POINTS ON THE PATIENT, IT FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609088 ↗
• MalfunctionJul 1, 2024Device Sensing Problem; Unintended Application Program Shut Down; Device Sensing Problem; Unintended Application Program Shut Down

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE BEING PERFORMED WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THERE WAS A LESS THAN 30 MINUTE SURGICAL DELAY, AND THERE WAS NO IMPACT TO THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646721 ↗