N/A 1885061HS (UDI 20763000041032)Recalls & reported problems
Medtronic Xomed, Inc. · BUR 1885061HS 3PK RND DIAMOND 5MM 15DEG · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20763000041032), received between Oct 9, 2024 and Aug 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Break
It was reported that the bur broke directly after it was placed in the nose. There were no patient symptoms/injuries related to this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50270028 ↗MalfunctionDec 22, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING TEAR FILM NASAL ANASTOMOSIS THE BUR SIDE SUCTION PORT OF THE BUR WAS BLOCKED AND ANOTHER SAMPLE BUR CONNECTION POINT WITH THE HANDPIECE WAS BROKEN DURING THE PROCEDURE. SOME FRAGMENT FELL ONTO THE OPERATING TABLE, BUT THE FRAGMENTS DID NOT ENTER THE BODY AND HAD NO IMPACT ON THE SURGERY. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23867645 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT DURING TRANSSPHENOIDAL BIOPSY BUR BROKEN. THE DEVICE WAS BEING OPERATED AS PER NORMAL UNTIL IT STOPPED MID USE. IT WAS REMOVED IMMEDIATELY FROM THE PATIENT, INSPECTED AND THEN REMOVED FROM HANDPIECE. THERE WERE NO FRAGMENTS CAME OFF THE BUR. THERE WAS NO DELAY TO PROCEDURE AND NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20405996 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- 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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