Quadcut® 1884380HRERecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884380HRE QUADCUT 4.3MM X 13CM · Class 1
All models of Quadcut (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000033910), received between Jul 5, 2021 and Jul 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Vibration” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 31, 2021Class IIOpen, Classified
There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0156-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2021Vibration; Vibration
A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE HCP NOTED SHE FELT THE BLADE WAS A LITTLE BIT WOBBLY AND NOT AS STIFF AS IT USUALLY IS. SHE DISCONTINUED USE OF THE BLADE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO INTERVENTION PERFORMED. THERE WAS 15 MINUTES DELAY. THERE WAS NO PATIENT INJURY. ON FOLLOW UP, IT WAS REPORTED THAT THE BLADE WAS BEING USED ON THE PATIENT WHEN THE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12115543 ↗
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
- 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
- N/A 1883502HREMedtronic 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 · each recall links to the FDA recall notice
- 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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