N/A 1884070RTCRecalls & reported problems
Medtronic Xomed, Inc. · BUR 1884070RTC REV TAP 70DG 4MM 13CM 30K · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169434585), received between Feb 28, 2018 and Jun 17, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Overheating of Device1
Patient problems
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE HAD PLASTIC STRAW INSIDE THE BUR. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22223250 ↗InjuryFeb 28, 2018Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE BUR GOT HOT AND HE LAID THE BUR AGAINST THE PATIENT'S NOSE AND IT BURNED THE SKIN. THE SALES REPRESENTATIVE SPOKE TO THE SCRUB TECHNICIAN AFTER THE CASE AND FELT THAT THE BUR WAS NOT SEATED CORRECTLY. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO RESPONSE YET RECEIVED.
Patient problems: Burn(s)
MAUDE report 7304140 ↗
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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