N/A 9734063 (UDI 00613994667472)Recalls & reported problems
Medtronic Navigation, Inc. · NAVIGATION INTERFACE 9734063 i7 220V · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994667472), received between Dec 5, 2018 and Feb 9, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection 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 16, 2026.
Most reported problems
Device problems
- Connection Problem1
- Human-Device Interface Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2021Connection Problem; Connection Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM DISPLAYED THERE WAS AN ELECTROMAGNETIC NAVIGATION INTERFACE UNIT COMMUNICATION ERROR. IT WAS REPORTED THAT THERE WAS NO COMMUNICATION AND THE PORT COULD NOT BE READ. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. TROUBLESHOOTING FOUND THAT THE REBOOTING THE NAVIGATION SYSTEM AND CHECKING THE CABLING DID NOT RESTORE FUNCTIONALITY. IT WAS ALSO NOTED THAT A CABLE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11301907 ↗MalfunctionDec 5, 2018Human-Device Interface Problem; Human-Device Interface Problem
MEDTRONIC RECEIVED INFORMATION THAT AN INTERFACE CABLE WAS DAMAGED ON THE SYSTEM. FOLLOWING REPLACEMENT BY A SITE BIOMEDICAL ENGINEER THE REPORTED ISSUE WAS RESOLVED.
Patient problems: No Patient Involvement
MAUDE report 8132685 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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