Tricut 1883504HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1883504HR TRICUT 5PK M4 3.5MM ROT · Class 1
All models of Tricut (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000518312), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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
- Material Separation1
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.
MalfunctionJan 18, 2022Material Separation; Material Separation
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT AFTER CORRECT SETUP OF THE BLADE, THE POLYPECTOMY PROCEDURE STARTED. UPON ACTIVATION OF THE BLADE, THE MOST DISTAL PORTION (TIP) HAS DETACHED WITHIN THE PATIENT'S NOSE SUDDENLY EMERGING FROM THE NASAL FOSSA (NASAL PASSAGE). IT WAS NOTED THAT THERE WAS NO BROKEN PIECES/FRAGMENTS OF THE REPORTED PRODUCT THAT REMAINED INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282349 ↗
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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