RAD 1884008Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884008 RADENOID 5PK 4MM · Class 1
All models of RAD (29)
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 20763000518145), received between Aug 20, 2024 and Aug 13, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
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 13, 2025Break; Break
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE BLADE SHAFT WAS BROKE WHILE USING ON PATIENT. THERE WERE NO FRAGMENTS DETACHED FROM THE BROKEN DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791750 ↗MalfunctionAug 1, 2025Break; Break
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE BLADE BROKE WHILE BEING USED ON A PATIENT. NO FRAGMENTS DETACHED FROM THE BROKEN BLADE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685169 ↗MalfunctionAug 20, 2024Break; Break
IT WAS REPORTED THAT DURING INTRA-OP, THE BLADE WAS CRACKED AND DAMAGED (SEPARATED INTO TWO PARTS). THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002900 ↗
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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