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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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Sources and updates

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