Oto-Flex 3155646Recalls & reported problems
Medtronic Xomed, Inc. · BUR 3155646 OTO-FLEX .6MM DIAMD BLUE/WH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000036065), received between Jul 9, 2024 and Sep 5, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Vibration” (4 reports).
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
- Vibration4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE SKEETER BURS WERE WOBBLING AFTER INSERTION. ALL THE FOUR BURS WERE TESTED WITH SAME HANDPIECE. THE PROCEDURE WAS COMPLETED USING OTHER BURS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145621 ↗MalfunctionSep 5, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE SKEETER BURS WERE WOBBLING AFTER INSERTION. ALL THE FOUR BURS WERE TESTED WITH SAME HANDPIECE. THE PROCEDURE WAS COMPLETED USING OTHER BURS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145603 ↗MalfunctionSep 5, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE SKEETER BURS WERE WOBBLING AFTER INSERTION. ALL THE FOUR BURS WERE TESTED WITH SAME HANDPIECE. THE PROCEDURE WAS COMPLETED USING OTHER BURS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20143992 ↗MalfunctionJul 9, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OPERATIVELY, THE BUR WAS PLACED IN THE SKEETER HANDPIECE AND PRESENTED NOTICEABLE OSCILLATION, SO IT WAS PLACED IN A SECOND SKEETER BUT THE OSCILLATION PROBLEM PERSISTED. WHEN A SECOND BUR WAS OPENED, IT ALSO PRESENTED THE SAME PROBLEM IN BOTH HANDPIECES BUT WITH LESS INTENSITY. THE BURS WERE NOT USED ON THE PATIENT. THE HANDPIECES ARE WORKING FINE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698563 ↗
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- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1884032Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MBUR5060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
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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