RAD 1883519HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1883519HR RAD90 3PK M4 3.5MM ROTAT · Class 1
All models of RAD (29)
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 20763000527239), received between Apr 17, 2023 and Jul 31, 2026 — 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.
MalfunctionJul 31, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094774 ↗MalfunctionOct 8, 2024Vibration; Vibration
IT WAS REPORTED THAT DURING FESS PROCEDURE, BLADE WAS USED IN SURGERY AND THE OUTER SHEATH WAS UNSTABLE AND SLIDING UP AND DOWN DURING THE PROCEDURE. MOVED ON TO A SECOND ONE AND THE OUT SHEATH WAS UNSTABLE, THE BLADE WAS UNSTABLE BECAUSE THE OUTER SHEATH WAS NOT SEALED TO THE HUB. THE THIRD SHAVER THEY PICKED WORKED AS EXPECTED. PROCEDURE EXTENDED BY 1 HOUR. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20393701 ↗MalfunctionDec 15, 2023Vibration; Vibration
ADDITIONAL INFORMATION RECEIVED THAT THE VIBRATING DEVICE WAS USED BEING USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333696 ↗MalfunctionApr 17, 2023Vibration; Vibration
IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE RAD90 WOULDN'T FIT THE HANDPIECE PROPERLY. THERE WAS CONCERN FOR VIBRATION. WHEN ENTERING THE SINUS, THE BLADE SHAFT WAS MOVING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS 5 MINUTES DELAY IN THE PROCEDURE AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750394 ↗
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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