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Fusion 9735704RRecalls & reported problems

Medtronic Navigation, Inc. · COMPUTER 9735704R FUSION COMPACT RFRB · 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 00643169791862), received between Jan 16, 2020 and Jan 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

  • Mechanical Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJan 16, 2020Mechanical Problem; Mechanical Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. AFTER LOADING MODEL EXAMS, THE IMAGES WERE PIXELATED. WHEN THE MANUFACTURER REPRESENTATIVE ENTERED THE "EDIT 3D MODEL TASK", THE SOFTWARE RESTARTED. THE SITE DID NOT HAVE ANY OTHER IMAGES TO TEST ON THE SYSTEM. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 9596514 ↗

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Sources and updates

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