RAD 1884016HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884016HR RAD60 5PK M4 4MM ROTATE · Class 1
All models of RAD (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20763000518343), received between Jan 31, 2024 and Aug 14, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (6 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
- Material Fragmentation6
- Break3
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Unintended Radiation Exposure1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT DURING OPERATION; BLADE WAS REPORTED TO HAVE THE FRONT TIP PROTRUDE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836315 ↗MalfunctionAug 8, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO CONNECT THE MOBILE PROGRAMMER BASE, FOLLOWING A SECOND ATTEMPT CONNECTION WAS ACHIEVED HOWEVER DURING THE PROCEDURE CONNECTION BETWEEN THE BASE AND TABLET WAS LOST WITH NO ELECTROGRAM ON THE RIGHT ATRIUM OR RIGHT VENTRICLE . THERE WAS NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747262 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE 60 BLADE CONNECTING TO AN M5 BROKE RIGHT AWAY WHEN STARTING THE M5 MOTOR. SWAPPED TO A DIFFERENT 60 DEGREE BLADE AND IT WAS A LOT 'SMOOTHER" WHEN CONNECTING TO THE M5. THE PROCEDURE WAS EXTENDED FOR LESS THAN A HOUR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22491948 ↗MalfunctionJan 31, 2024Break; Break
IT WAS REPORTED THAT, IN REMOVING FROM PATIENT IT WAS NOTICED THE BLADE WAS BROKEN. FRAGMENTS FELL INTO THE PATIENT BODY AND THE BROKEN PIECES(S) RETRIEVED FROM INSIDE THE PATIENT'S BODY. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Unintended Radiation Exposure
MAUDE report 18611717 ↗
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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