N/A 1884002HRERecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884002HRE M4 SERR 4MM ROTATE1 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074080994), received between Oct 8, 2018 and Jan 29, 2020 — classified as 3 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 18, 2026.
Most reported problems
Device problems
- Break2
- Material Separation1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2020Break; Break
A HEALTH CARE PROVIDER (HCP) REPORTED THAT A BLADE TIP WAS DAMAGED. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9641351 ↗MalfunctionMay 15, 2019Material Separation; Material Separation
A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE INNER BLADE CAUGHT THE OUTER SHEATH OF THE BLADE AND CONTINUED TO SHEAR OUT. IT WAS THE INITIAL USE OF THE BLADE. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. IT WAS NOTED THAT THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8613783 ↗MalfunctionOct 8, 2018Break; Obstruction of Flow; Break; Obstruction of Flow
A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE HAD BEEN BLOCKED, THE INNER PART OF THE BLADE CAME PARTLY OUT FROM THE TIP OF THE BLADE DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7945157 ↗
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 1882936EMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- N/A 1884033Medtronic Xomed, Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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