N/A 9733879 (UDI 00763000053536)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000053536), received between Jan 7, 2019 and Mar 4, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE ACTIVE FRAME SUDDENLY BECAME UNDETECTABLE, ALTHOUGH THE PASSIVE PROBE WAS RECOGNIZED. NEITHER RESTARTING THE SYSTEM NOR REPLACING THE ACTIVE FRAME RESOLVED THE ISSUE. IT WAS NOTED THAT THERE WAS AN ISSUE WITH INACCURACY THAT APPLIED TO ALL INSTRUMENTS. AFTER A WHILE, THE ACTIVE FRAME WAS RECOGNIZED, BUT THE ACCURACY WAS GREATLY MISALIGNED. THE USE OF NAVIGATION WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED. IT WAS ALSO NOTED THAT THERE WAS MAIN MONITOR ARM AND CAMERA GRIP DAMAGE. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513742 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LINEAR BLUNT PROBE INSTRUMENT MALFUNCTIONED AND DISCONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650223 ↗
• MalfunctionJul 16, 2025Material Fragmentation; Device Sensing Problem; Material Fragmentation; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THERE WAS A CABLE FRACTURE. THE PROBE WAS NOT RECOGNIZED; CABLE DISCONNECTION. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520222 ↗
• MalfunctionOct 23, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS NOT RECOGNIZED DUE TO DISCONNECTION DUE TO DETERIORATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518306 ↗
• MalfunctionMay 24, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A TUMORECTOMY. IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO BE RECOGNIZED. THE SITE WAS ABLE TO CONTINUE TO A DIFFERENT PROBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997196 ↗
• MalfunctionApr 13, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED ONE LED ON THE BLUNT PROBE WAS VISIBLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655570 ↗
• MalfunctionOct 6, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A TUMORECTOMY. IT WAS REPORTED THAT A PROBE HAD RECOGNITION FAILURE. ANOTHER PROBE WAS USED. IT WAS NOTED THAT THE SUSPECTED CAUSE WAS DUE TO DETERIORATION OF THE PROBE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10637792 ↗
• MalfunctionJan 7, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PROBE BEING USED WITH A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE, ONE LED LIGHT OF THE LONG CABLE HAD RECOGNITION FAILURE. THE PROCEDURE WAS PERFORMED USING ANOTHER ACTIVE PROBE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222779 ↗