Tricut 1884080HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884080HR 5PK TRICUT M4 13CM 4MM · Class 1
All models of Tricut (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000543826), received between Jan 12, 2023 and Mar 25, 2024 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Break; Noise, Audible; Break; Noise, Audible
ADDITIONAL INFORMATION RECEIVED THAT THE INNER SHEATH BROKE APART AND MADE A WHIRLING SOUND. SURGEON WAS ABLE TO SEE THE MOMENT THE TRICUT BLADE BROKE AND REMOVED IT FROM THE PATIENT¿S NOSE WHEN IT STOPPED ROTATING. SURGEON REMOVED THE BLADE OFF THE M5 HANDPIECE AND INNER CANNULA WAS BROKEN IN HALF. SURGEON (ENDOSCOPICALLY) SEARCHED PATIENT¿S NOSE FOR POTENTIAL DEBRIS AND DID NOT FIND ANY METAL FRAGMENT/PIECES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966982 ↗MalfunctionJan 12, 2023Break; Break
IT WAS REPORTED BY HCP THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE QUADCUT BLADE BROKE DURING USE DESPITE CORRECT INSTALLATION AND USE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16143768 ↗
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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