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N/A 9734259Recalls & reported problems

Medtronic Navigation, Inc. · DRIVER 9734259 ORANGE ASSY · Class 2

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 00613994671882), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 14, 2020Material Integrity Problem; Material Integrity Problem

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (CONFIRMED VIA HEALTHCARE PROVIDER) INDICATED THE LIKELY CAUSE OF THE REPORTED INSTRUMENT TRACKER ISSUE WAS INSTRUMENT DETERIORATION. IT WAS CONFIRMED INSTRUMENT TRACKER REGISTRATION WAS ULTIMATELY POSSIBLE. THE PROCEDURE WAS COMPLETED WITH THE AFOREMENTIONED INSTRUMENT TRACKER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9588266 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.