N/A 1882940HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1882940HR 5PK M4 INF TURB 2.9MM · Class 1
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 20885074079817), received between Oct 23, 2018 and Jul 31, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Vibration” (2 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
- Vibration2
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094553 ↗MalfunctionJun 17, 2021Vibration; Vibration
IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS WOBBLY. THE DEVICE HAD IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED BY A BACK UP DEVICE WITH 30 MINUTES DELAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12017238 ↗MalfunctionNov 26, 2019Vibration; Vibration
A HEALTH CARE PROVIDER (HCP) REPORTED THAT A BLADE WAS NOT STABLE (SHAKING) AFTER CONNECTING TO THE HP AND ACTIVATED DURING OPERATION. THE PROCEDURE WAS COMPLETED WITH A NEW BLADE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9377051 ↗MalfunctionOct 23, 2018Material Separation; Material Separation
A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE HAD CAME APART ONCE IT WAS USED DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE O-RING CAME OFF COMPLETELY AND GOT STUCK IN THE HANDPIECE BUT IT WAS ALSO RETRIEVED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AND A BACK-UP DEVICE WAS USED AND IT FUNCTIONED FINE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7996638 ↗
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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