N/A 9733881 (UDI 00643169545588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169545588), received between Mar 8, 2017 and Sep 26, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING REGISTRATION AND THE STERILE SETUP, THE ACTIVE FRAME WAS RECOGNIZED, AND THE NAVIGATION SYSTEM WAS IN USE. HOWEVER, PARTWAY THROUGH, TRACKING THE ACTIVE FRAME BECAME UNRELIABLE. WHILE IT WAS BRIEFLY RECOGNIZED, IT FAILED TO BE RECOGNIZED FOR MOST OF THE TIME. THE PASSIVE PROBE TRACKED WITHOUT ISSUE. BOTH THE STERILE AND NON-STERILE ACTIVE FRAMES WERE TESTED, BUT NO IMPROVEMENT WAS OBSERVED. RESTARTING THE SYSTEM ALSO DID NOT RESOLVE THE ISSUE. NAVIGATION WAS ABORTED, AND THE SURGERY WAS COMPLETED WITHOUT NAVIGATION. POST-SURGERY, THE SYSTEM WAS CHECKED BUT REMAINED UNSTABLE. DURING MAINTENANCE, IT WAS DETERMINED THAT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU), BREAKOUT BOX, AND ACTIVE FRAME × 2 HAD BEEN DISCONTINUED, LEADING TO A TRANSITION TO THE PASSIVE FRAME. THE RECOGNITION FAILURE AND DEFECT OCCURRED DURING USE OF THE CRANIAL FRAME. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23157519 ↗
• MalfunctionJul 28, 2025Material Fragmentation; Device Sensing Problem; Material Fragmentation; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A TUMORECTOMY PROCEDURE. IT WAS REPORTED THAT THE CONNECTION WITH THE CRANIAL FRAME WAS UNSTABLE EVEN WHEN THE CABLE WAS PLUGGED IN. A SPARE FRAME WAS USED INSTEAD. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THE SUSPECTED CAUSE OF THE ISSUE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635988 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING THE INSPECTION, A DISCONNECTION IN THE SMALL ACTIVE CRANIAL FRAME WAS CONFIRMED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENT GOT DAMAGED OR WHAT LEAD TO THE INSTRUMENT BEING DAMAGED WAS DUE TO DETERIORATION OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144313 ↗
• MalfunctionMar 7, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A TUMORECTOMY. IT WAS REPORTED THAT THE SYSTEM HAD ISSUES RECOGNIZING THE ACTIVE FRAME. IT WAS REPORTED THAT THE ACTIVE FRAME MAY BECOME MISRECOGNIZED. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE FRAME RECOGNITION ISSUE WERE RESOLVED VIA TROUBLESHOOTING FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551901 ↗
• MalfunctionMay 17, 2021Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS A TRACKING FAILURE. NO TROUBLESHOOTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832875 ↗
• MalfunctionSep 14, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ACTIVE CRANIAL REFERENCE FRAME HAD A RECOGNITION FAILURE AND COULD NOT BE TRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10529115 ↗
• MalfunctionApr 16, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH AN ACTIVE CRANIAL REFERENCE FRAME NOT CONNECTING TO THE NAVIGATION SYSTEM. THE CRANIAL REFERENCE FRAME IS DAMAGED; FRACTURE WAS SUSPECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACTIVE CRANIAL FRAME. THERE WAS NO REPORTED DELAY OR IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9967500 ↗
• MalfunctionNov 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS CONFIRMED ONE LED LIGHT WENT OUT (ALSO REPORTED AS NOT RECOGNIZED) DURING A MAINTENANCE CHECK. FRAME REPLACEMENT WAS SCHEDULED FOR A LATER DATE.

  Patient problems: No Patient Involvement

  MAUDE report 9304803 ↗
• MalfunctionMar 4, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A TUMORECTOMY, THE NAVIGATION SYSTEM COULD NOT RECOGNIZE THE CRANIAL ACTIVE REFERENCE FRAME BEING USED IN THE PROCEDURE. 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 REPORTED IMPACT ON PATIENT OUTCOME. FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT THE ISSUE COULD BE REPLICATED ON THE REFERENCE FRAME IN QUESTION AS A RECOGNITION FAILURE OCCURRED IN BOTH STERILE AND NON-STERILE FIELDS. IT WAS NOTED THAT A SEPARATE CRANIAL REFERENCE FRAME COULD BE TRACKED BY THE NAVIGATION SYSTEM DURING TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387201 ↗
• MalfunctionJan 17, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SMALL CRANIAL ACTIVE FRAME LONG CABLE HAD A RECOGNITION FAILURE. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8258793 ↗
• MalfunctionMar 8, 2017Device Inoperable; Device Inoperable

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT THAT, WHILE IN A CRANIAL PROCEDURE, AN LED LIGHT WENT OUT ON A CRANIAL ACTIVE FRAME THE SITE WAS USING. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. TO CONTINUE THE PROCEDURE, THE SITE USED A BACK-UP CABLE AND A SECOND INSTRUMENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6388034 ↗