RAD® 1884006Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884006 RAD40 5PK SINUS 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 20681490047474), received between Jul 6, 2021 and Jan 30, 2025 — classified as 3 malfunctions.
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
- Material Fragmentation1
- Vibration1
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.
MalfunctionJan 30, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING. SHE FOUND THE BLADE HAD OBVIOUSLY SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272720 ↗MalfunctionMar 26, 2024Break; Break
IT WAS REPORTED THAT INTRA OP DURING FESS PROCEDURE, WHEN THE DOCTOR USED THE BLADE FOR ABOUT 5 MINUTES, HE FOUND THAT THE INNER SHAFT BROKE AT THE MIDDLE END. SO, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. THERE WERE NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN BLADE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976651 ↗MalfunctionJul 6, 2021Material Fragmentation; Material Fragmentation
A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE DISTAL TIP/HEAD AND INNER CUTTER OF THE BLADE WAS BROKEN DURING USE IN A PROCEDURE. THERE WERE SOME FRAGMENTS THAT FELL OFF AND WERE REMOVED BY GRASPING FORCEPS. THEY JUST STARTED TO USE THE NEW BLADE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122706 ↗
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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