N/A 1884080HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884080HR 5PK TRICUT M4 13CM 4MM · 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 20613994233329), received between Dec 18, 2018 and Sep 10, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Material Fragmentation1
- Material Separation1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2019Material Fragmentation; Material Fragmentation
A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING TRANS SPHENOIDAL RESECTION OF PITUITARY TUMOR, THE TIP OF THE BUR BROKE OFF INSIDE THE PATIENT'S SPHENOID SINUS. THE BROKEN TIP WAS RETRIEVED AND REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT ALL PIECES WERE REMOVED BY THE SURGEON. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8978955 ↗MalfunctionMay 23, 2019Break; Break
A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR BROKE DURING A PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8635780 ↗MalfunctionMay 20, 2019Break; Mechanical Jam; Break; Mechanical Jam
ADDITIONAL INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WERE NO FRAGMENTS DETACHED. THE BLADE JUST CEASED TO FUNCTION OR OSCILLATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625813 ↗MalfunctionDec 18, 2018Material Separation; Material Separation
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE SURGEON WAS REMOVING A NASAL SPUR AND THEY NOTICED A PIECE OF THE BLADE BROKEN OFF AND FOUND IT IN THE NASAL CAVITY AND REMOVED IT. PATIENT WAS UNHARMED IN THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8175365 ↗
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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