RAD 1884012Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884012 RAD12 5PK CURVED 4MM · Class 1
All models of RAD (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000518152), received between Apr 9, 2024 and Jul 30, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Vibration” (3 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
- Vibration3
- Break2
- Failure to Cut1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT DURING INTRA-OPERATION, THE BLADE WAS USED FOR THE FIRST TIME 20 MINUTES AFTER USE, THE BLADE COULD NOT CUT NORMALLY. UPON INSPECTION, THE TAIL END OF THE BLADE FELL OFF WHILE IN USE ON A PATIENT AND COULD NOT BE USED FOR FURTHER SURGERY. THE TIP OF THE BUR FELL OFF AND WAS REMOVED BY THE SURGEON USING FORCEPS AND DISCARDED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22661230 ↗MalfunctionJun 20, 2025Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO USE, THE BLADE COULD NOT BE ROTATED WHEN INSTALLED ON THE HANDPIECE. AFTER REPLACING ANOTHER BLADE, IT COULD BE USED NORMALLY. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295006 ↗MalfunctionMay 12, 2025Vibration; Vibration
ADDITIONAL INFORMATION THAT THE BLADE WAS CHECKED PRIOR TO USE AND IT WAS VIBRATING, THAT WAS WHEN IT WAS PULLED AND NOT USED. THERE WAS NO PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22001008 ↗MalfunctionJan 29, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO OPERATION WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THAT THE BLADE HAD VISIBLY SHAKING. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21270636 ↗MalfunctionApr 9, 2024Vibration; Vibration
IT WAS REPORTED THAT FROM THE VERY BEGINNING OF THE MILLING PROCESS, THE BLADE WAS DEFECTIVE, VIBRATING AND MOVING FROM RIGHT TO LEFT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069056 ↗
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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