Oto-Flex 3155647Recalls & reported problems
Medtronic Xomed, Inc. · BUR 3155647 OTO-FLEX .7MM DIAMD GRN/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 00763000036072), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Vibration” (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.
Reports received per month
Most reported problems
Device problems
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2024Vibration; Vibration
IT WAS REPORTED THAT DURING HYSTERECTOMY PROCEDURE, THE PRODUCT HAD SHAKING WHEN FIRST USED, BUT AS IT WAS NOT A VERY SENSITIVE AREA, THE DOCTOR WAS ABLE TO USE IT. WHEN TRYING TO USE IT FOR THE SECOND TIME, EVEN AFTER CARRYING OUT SEVERAL TESTS, THE SHAKING PROBLEM PERSISTED. THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE PROCEDURE WAS PERFORMED WITH ANOTHER INSTRUMENT. PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. TESTS WERE CARRIED OUT ON THE DAY WITH THREE DIFFERENT BURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162037 ↗
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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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