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N/A 3155648Recalls & reported problems

Medtronic Xomed, Inc. · BUR 3155648 OTO-FLEX .8MM DIAMD YEL/WH · Class 1

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 00681490070584), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

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.

  • MalfunctionFeb 28, 2020Material Separation; Material Separation

    IT WAS REPORTED THAT PRE OPERATIVELY THE DEVICES WERE BROKEN UPON OPENING IT FROM THE SEALED PACK. BOTH TIPS WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW UP IT WAS CONFIRMED THAT IT WAS THE DISTAL TIP OF THE DEVICE THAT WAS BROKEN, THERE WAS NO FRAGMENT DETACHED. A NEW BUR WAS USED AND COMPLETED THE PROCEDURE WITH AROUND 10MINUTES OF DELAY.

    Patient problems: No Patient Involvement

    MAUDE report 9770476 ↗

Other BUR, EAR, NOSE AND THROAT devices

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Sources and updates

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