N/A 9735319Recalls & reported problems
Medtronic Navigation, Inc. · POINTER 9735319 NAVIGATION AXIEM PKGD · Class 2
Data updated Oct 16, 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 00643169490048), received between Jun 23, 2026 and Jun 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionJun 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE PLACED THE POINTER ON THE TIP OF THE NOSE AND IT INDICATED THATTHEY WERE INSIDE OF THE CRANIAL VAULT. THE ESTIMATED AMOUNT OF INACCURACY OBSERVED WAS 10 MM. ONCE THE INACCURACY WAS DISCOVERED, THE ACCURACY WAS RESTORED TWICE USING CHECKPOINTS TAKEN BEFORE THE START OF SURGERY. IT WAS NOTED THAT NAVIGATION WAS DISCONTINUED. TO CONTINUE WITH THE PROCEDURE, THE IMPLANT HAD TO BE REGISTERED SEVERAL TIMES IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25602421 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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