Tricut 1883504Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1883504 TRICUT 5PK 3.5MM · Class 1
All models of Tricut (17)
Data updated Oct 16, 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 20763000518121), received between Jun 22, 2022 and Jan 28, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USE, WHEN THE DOCTOR INSTALLED BLADE INTO THE HANDPIECE FOR TESTING, FOUND THAT THE TIP OF BLADE WOULD OSCILLATE. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21250188 ↗MalfunctionNov 22, 2023Break; Break
IT WAS REPORTED THAT DURING FESS SURGERY, THE TIP OF THE BLADE SNAPPED OFF. CONCHA BULOSA WAS BEING DEBRIDED AT THE TIME OF THE INCIDENT. THERE WERE NO BROKEN PIECES OF THE REPORTED PRODUCT THAT REMAINED INSIDE THE PATIENT'S BODY. THE SURGEON USED A FORCEPS TO REMOVE THE BUR FROM THE NASAL CAVITY. THE OUTER SHAFT WAS NOT PREVENTED THE FRAGMENTS FROM FALLING OUT AND CONTACTING THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18188856 ↗MalfunctionJun 22, 2022Break; Break
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A TRANSSPHENOIDAL CASE, THE HEAD OF THE SHAVER BLADE AND THE DISTAL TIP OF THE INNER BLADE CAME APART, SHEARED OFF AND WAS NOT CONTAINED IN THE OUTER SHAFT. NOT SURE IF THE TIP GOT SUCKED UP (SUCTION) OR IF IT CAME OUT; CHECKED THE DRAPES, PERFORMED AN X-RAY BUT DIDN¿T FIND IT STILL IN THE PATIENT, NEVER FOUND THE TIP. THE EVENT ADDED ABOUT 10 MIN TO THE CASE AND THEN HAVING TO WAIT FOR AN X-RAY AFTER, BUT THERE WAS NO PATIENT IMPACT. THE HANDPIECE WAS RUNNING AT 5000 RPM IN OSCILLATE MODE. ANOTHER BLADE WAS OPENED TO COMPETE THE SURGERY. ON FOLLOW-UP, IT WAS REPORTED THAT THE TIP WAS NEVER FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure
MAUDE report 14767677 ↗
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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