N/A 960-539 (UDI 00763000337131)Recalls & reported problems
Medtronic Navigation, Inc. · INST 960-539 GUIDE BIOPSY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000337131), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Component Missing; Activation, Positioning or Separation Problem; Component Missing; Activation, Positioning or Separation Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A BRAIN BIOPSY. IT WAS REPORTED THAT THE BIOPSY GUIDE FAILED TO LOCK SECURELY, DURING INSTRUMENT INSTALLATION, EVEN WHEN THE LOCKING MECHANISM WAS FULLY ENGAGED, DUE TO THE ABSENCE OF THE CONNECTION POINT'S POSITIONING PIN. THE DOCTOR HAD TO USE ANOTHER TOOL TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT AND NO REPORTED DELAY. ANESTHESIA HAD BEEN ADMINISTERED WHEN THE ISSUE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073020 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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