RADRecalls & reported problems across all models
Medtronic Xomed, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one RAD model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 183
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 29 models of RAD by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2017 and Sep 28, 2026 — classified as 2 injuries, 181 malfunctions.
The most frequently reported specific device problem is “Break” (96 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
RAD recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2021Open, Classified
There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0156-2022 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported RAD problems
Device problems
- Break96
- Vibration50
- Material Fragmentation24
- Material Separation10
- Mechanical Jam5
- Connection Problem4
- Material Protrusion/Extrusion4
- Use of Device Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- No Consequences Or Impact To Patient50
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- No Information1
- No Patient Involvement1
- Oversedation1
RAD models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RAD® 1882916BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1883512HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- RAD® 1883506HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- RAD® 1883516HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- RAD® 1883514BUR, EAR, NOSE AND THROAT1 recall0 reports
- RAD® 1883070HSBUR, EAR, NOSE AND THROAT25 reports
- RAD® 1884006HRBUR, EAR, NOSE AND THROAT24 reports
- RAD 1884006BUR, EAR, NOSE AND THROAT16 reports
- RAD® 1883519HRBUR, EAR, NOSE AND THROAT16 reports
- RAD® 1883670HSBUR, EAR, NOSE AND THROAT14 reports
- RAD 1884006HRBUR, EAR, NOSE AND THROAT12 reports
- RAD 1884016HRBUR, EAR, NOSE AND THROAT10 reports
- RAD® 1884012HRBUR, EAR, NOSE AND THROAT10 reports
- RAD® 1884016HRBUR, EAR, NOSE AND THROAT10 reports
- RAD® 1884008BUR, EAR, NOSE AND THROAT7 reports
- RAD® 1882916BUR, EAR, NOSE AND THROAT7 reports
- RAD® 1884012BUR, EAR, NOSE AND THROAT6 reports
- RAD 1884012BUR, EAR, NOSE AND THROAT5 reports
- RAD 1883519HRBUR, EAR, NOSE AND THROAT4 reports
- RAD® 1884006BUR, EAR, NOSE AND THROAT3 reports
- RAD® 1884507BUR, EAR, NOSE AND THROAT3 reports
- RAD 1884008BUR, EAR, NOSE AND THROAT3 reports
- RAD® 1884006HREBUR, EAR, NOSE AND THROAT1 report
- RAD® 1883506HREBUR, EAR, NOSE AND THROAT1 report
- RAD® 1883516HREBUR, EAR, NOSE AND THROAT1 report
- RAD® 1884016BUR, EAR, NOSE AND THROAT1 report
- RAD 1884016BUR, EAR, NOSE AND THROAT1 report
- RAD 1883517BUR, EAR, NOSE AND THROAT1 report
- RAD® 1883517BUR, EAR, NOSE AND THROAT1 report
Recent RAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Vibration
It was reported that during the surgery, it was discovered that the blade could not make the cut. The procedure was completed with backup product. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910716 ↗MalfunctionSep 11, 2026Break
It was reported that tip of the blade snapped into half during use. There was a unexpected or prolonged care There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731000 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247973 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247967 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247962 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247960 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247930 ↗MalfunctionAug 5, 2026Mechanical Problem; Vibration
It was reported that intra-op during the procedure, the rotation was not smooth, turning intermittently and unable to rotate fully into position, with a loud noise. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139076 ↗MalfunctionJul 31, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094774 ↗MalfunctionJul 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25902469 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT DURING FASS PROCEDURE, BLADE BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT, EXTENDED TIME BY 2 HOURS. CONFIRMED BY THE USER THAT NO FRAGMENTS DETACHED FROM THE DEVICE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320529 ↗MalfunctionDec 29, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING ESS PROCEDURE, THE TIP OF THE BLADE CAME OFF DURING USE OF THIS PRODUCT. THE OPERATION WAS CONTINUED BY REPLACING IT WITH A NEW ONE. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907197 ↗MalfunctionDec 28, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING THE ESS PROCEDURE, THERE WAS AN UNUSUAL DISCOMFORT (A SENSATION THAT THE BLADE TIP WAS FLOATING). RESETTING DID NOT CHANGE THE SITUATION, SO IT WAS DETERMINED TO BE A MALFUNCTION. A SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904067 ↗MalfunctionDec 25, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion
IT WAS REPORTED THAT INTRA OP, THE BLADE WAS BROKEN AND THE TIP PROTRUDES AND SHAVING CANNOT BE PERFORMED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894524 ↗MalfunctionDec 25, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion
IT WAS REPORTED THAT INTRA OP, THE BLADE WAS BROKEN AND THE TIP PROTRUDES AND SHAVING CANNOT BE PERFORMED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894520 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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