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Tricut® 1884031Recalls & reported problems

Medtronic Xomed, Inc. · BLADE 1884031 RAD TRICUT 3PK 4MM 27.5CM · Class 1

All models of Tricut (17)

Data updated Oct 18, 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 20681490047634), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

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 30, 2021Material Fragmentation; Material Fragmentation

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE TIP BROKE DUE TO USE OF HIGH RPM AS COMPARED TO THE IFU DURING THE ONCOLOGY PROCEDURE. THERE WERE FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BROKEN DEVICE AND THE FRAGMENT GET IN CONTACT WITH THE PATIENT. THE FRAGMENTS WERE REMOVED FROM THE PATIENT BY HAND. A NEW BLADE WAS USED. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WERE NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12254476 ↗

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Sources and updates

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