N/A 1883673HSRecalls & reported problems
Medtronic Xomed, Inc. · BUR 1883673HS 3PK CHOANAL ATRESIA TAPER · 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 20721902686201), received between Nov 20, 2017 and Sep 14, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2018Material Separation; Material Separation
THE HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING ENDOSCOPIC SINUS SURGERY WHILE DRILLING WAS PERFORMED IN THE NASAL CAVITY, IT SEEMED THAT FORCE WAS APPLIED AND THE TIP OF THE BUR BROKE. THE TIP OF THE BUR WAS BROKEN IN THE MAXILLARY SINUS OF THE NASAL CAVITY AND TIP CAME OFF. THE BROKEN TIP WAS TAKEN OUT IMMEDIATELY BY ASPIRATION. THERE WAS A PROCEDURE DELAY OF 10 MINUTES AND WAS COMPLETED USING A BACKUP PRODUCT. NO BROKEN PIECES OF THE BUR REMAINED IN THE PATIENTS BODY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7878038 ↗MalfunctionJun 4, 2018Break; Break
THE BUR BROKE AS SOON AS IT CONTACTED BONE. THERE WAS NO PATIENT IMPACT OR INJURY. THERE WERE NO FRAGMENTS THAT NEEDED TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7566543 ↗MalfunctionMar 27, 2018Break; Break
THE CUSTOMER REPORTED THAT WHILE THE HIGH SPEED CHOANAL ATRESIA BUR WAS IN USE DURING A DACRYOCYSTORHINOSTOMY, THE BASE OF THE INNER CYLINDER WAS BROKEN. THERE WAS NO PATIENT IMPACT OR INJURY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7373419 ↗MalfunctionNov 20, 2017Break; Break
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THE BUR WAS BEING USED AT A HIGH SPEED WITH THE M4 MICRODEBRIDER HANDPIECE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7045763 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page