N/A 9734887Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169488113), received between Mar 31, 2017 and May 19, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THERE WERE ISSUES WITH VERIFICATION DURING A CASE ISSUES WITH VERIFYING SUCTIONS. ATTEMPTED TO VERIFY A STRAIGHT SUCTION USING INSTRUMENT TRACKER ONE, AND IT WOULD NOT VERIFY. ATTEMPTED TO VERIFY A 90-DEGREE SUCTION WITH INSTRUMENT TRACKER TWO AND IT WOULD NOT VERIFY. SWAPPED INSTRUMENT TRACKER ONE TO THE 90-DEGREE SUCTION AND IT VERIFIED. SWAPPED INSTRUMENT TRACKER ONE BACK TO THE STRAIGHT SUCTION AND IT VERIFIED. THERE WAS A REPORTED DELAY OF LESS THAN AN HOUR. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044700 ↗
• MalfunctionOct 10, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A TUMOR RESECTION. IT WAS REPORTED THAT THE NON-INVASIVE TRACKER WAS NOT TRACKING. THIS WAS AN OUT OF BOX ISSUE. THIS WAS THE ONLY INSTRUMENT HAVING ISSUES. THE OTHER INSTRUMENTS WERE WORKING. NAVIGATION WAS ABORTED CAUSING NO DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418618 ↗
• MalfunctionOct 26, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ISSUES REGISTERING. HOWEVER, WHEN THE SURGEON WAS READY TO PLACE THE SHUNT, THERE WERE COMMUNICATION ISSUES WITH THE NON-INVASIVE PATIENT TRACKER (NIPT). THE NIPT WAS SHOWING AS RED AND NOT LISTING A GEOMETRY ERROR. MOVING THE EMITTER DID NOT IMPROVE TRACKING. HOWEVER, OTHER INSTRUMENTATION WAS ABLE TO TRACK. THE SURGEON FREE HANDED THE REMAINDER OF THE SURGERY. THIS WAS AN OUT-OF-BOX ISSUE WITH THE INSTRUMENT. THE PROCEDURE WAS DELAYED BY 10 MINUTES AND THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698549 ↗
• MalfunctionAug 27, 2020Device Sensing Problem; Device Sensing Problem

  THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462566 ↗
• InjuryMay 28, 2019Excessive Heating; Excessive Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A TUMOR RESECTION PROCEDURE AND CAUSED NO DELAY TO THE PROCEDURE. IT WAS REPORTED THAT A PATIENT WHO HAD AN MRI WITH THE STINGRAY TRACKER ON RECEIVED A BUR IN SHAPE OF THE TRACKER. THE DOCTOR REPORTED THAT THE BURN WAS HEALING. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE WAS NOT FOLLOWING MRI SAFETY PROTOCOL AND THE CABLE WAS NOT BUNDLED PER INSTRUCTIONS. THE PROCEDURE WAS A TUMOR RESECTION. THEY WERE ABLE TO REMOVE ALL OF THE TUMOR AND THE PATIENT IS HEALING JUST FINE.

  Patient problems: Burn(s)

  MAUDE report 8646808 ↗
• MalfunctionApr 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY LESS THAN ONE HOUR. IT WAS REPORTED THAT THE TRACKER MALFUNCTIONED DURING A CASE. THE SITE OPENED A SECOND DEVICE AND THAT INSTRUMENT WORKED FINE. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478129 ↗
• MalfunctionJan 18, 2018Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE PATIENT TRACKER LOST COMMUNICATION WITH THE INTERFACE BOX OF THE NAVIGATION SYSTEM. IT WAS REPORTED THAT MULTIPLE PORTS WERE ATTEMPTED TO BE USED WITHOUT RESOLUTION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204032 ↗
• MalfunctionMay 11, 2017Device Inoperable; Communication or Transmission Problem; Material Deformation; Device Inoperable; Communication or Transmission Problem; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THE SITE HAD A DAMAGED PATIENT TRACKER WITH VERIFICATION ISSUES. THE PATIENT TRACKER WAS WORKING THE SUDDENLY BECAME UNVERIFIED. THIS OCCURRED DURING ACTIVE NAVIGATION. THE DAMAGED PATIENT TRACKER WAS REPLACED WITH A BACK-UP INSTRUMENT AND THE PROCEDURE CONTINUED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562323 ↗
• MalfunctionApr 20, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), SOME ADHESIVE MATERIAL FROM THE PATIENT TRACKER REMAINED ON THE PATIENT RATHER THAN ON THE TRACKER. THE PATIENT'S FOREHEAD WAS REPORTED TO BE A BIT RED FOLLOWING THE REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508124 ↗
• InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE NON-INVASIVE PATIENT TRACKER PRODUCED "SKIN DAMAGE" ON THE PATIENT'S FOREHEAD. THE PATIENT WAS IN A PRONE POSITION FOR THE SEVEN HOUR SURGERY. THE REP POSTULATED THAT THE PATIENT TRACKER WAS NOT MAKING DIRECT CONTACT WITH THE HORSESHOE HEADHOLDER, BUT WAS UNABLE TO VISUALLY CONFIRM THIS DURING THE SURGERY. THE SYSTEM PERFORMED AS EXPECTED THROUGHOUT THE CASE. THE SKIN DAMAGE WAS IDENTIFIED ONE DAY AFTER THE SURGERY AND THE HOSPITAL WAS UNABLE TO SPECIFY WHAT TYPE OF SKIN DAMAGE OCCURRED.

  Patient problems: Iatrogenic Source; Skin Irritation; Tissue Damage

  MAUDE report 6449280 ↗