N/A 9733881 (UDI 00613994480637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994480637), received between Nov 30, 2017 and Nov 4, 2025 — classified as 10 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Device Sensing Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A DISCONNECTION OF THE ACTIVE FRAME WAS SUSPECTED. INTERMITTENT RESPONSIVENESS WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465212 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE CORD OF THE FRAME WAS DISCONNECTED BY THE BLADE. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THERE WAS NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS CONFIRMED THAT THE BLADE HAD SEVERED THE CORD OF THE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397611 ↗
• MalfunctionFeb 11, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A BRAIN TUMOR REMOVAL PROCEDURE. IT WAS REPORTED THAT ONE LED WAS NOT RECOGNIZED. THE INSTRUMENT WAS REPLACED WITH ANOTHER DEVICE OWNED BY THE HOSPITAL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE DID NOT CAUSE ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355948 ↗
• MalfunctionJan 22, 2025Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS CABLE BREAKAGE AND DEFORMATION. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210688 ↗
• MalfunctionSep 6, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ONLY ONE SENSOR DID NOT RESPOND, IT WAS STILL IN RED.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159201 ↗
• MalfunctionDec 13, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A TUMORECTOMY. IT WAS REPORTED THAT THE ACTIVE CRANIAL FRAME WAS DISCONNECTED. THE USE OF NAVIGATION WAS STOPPED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969464 ↗
• MalfunctionJan 8, 2021Device Sensing Problem; Material Integrity Problem; Device Sensing Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140105 ↗
• 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 8387195 ↗
• MalfunctionDec 18, 2018Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. THE INFORMATION RECEIVED WAS CONTRADICTING AND WE ARE FOLLOWING UP TO CONFIRM THE INFORMATION. IT WAS REPORTED THAT ONE OF THE LED LIGHTS HAD A RECOGNITION FAILURE. THE PROCEDURE WAS COMPLETED WITH THE CONTINUOUS USE OF THE FRAME. THE SITE WAS ABLE TO COMPLETE THE PROCEDURE WITH THE USE OF THE FRAME. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: Complaint, Ill-Defined; No Known Impact Or Consequence To Patient

  MAUDE report 8175256 ↗
• MalfunctionNov 30, 2017Device Stops Intermittently; Communication or Transmission Problem; Device Stops Intermittently; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING CRANIAL RESECTION PROCEDURE,THE NAVIGATION SYSTEM INTERMITTENTLY COULD NOT SEE THE LEDS OF THE ACTIVE HEAD FRAME . THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070440 ↗