Tricut® 1883504Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20681490047368), received between Oct 16, 2018 and Oct 22, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2021Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE FRONT END OF THE BLADE WAS BROKEN 15 MINUTES AFTER THE PROCEDURE BEGAN. THE HCP SAID THAT THE PRODUCT WAS UNDER NORMAL USAGE FLOW. THE HCP THEN USED X-RAY TO CHECK AND CLEANED THE PIECES OUT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) ON FOLLOW UP, IT WAS STATED THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12678376 ↗
• MalfunctionMay 17, 2021Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE TIP WAS BROKEN-DETACHED ABOUT 5 MINUTES DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THERE WERE FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BUR. THE FRAGMENTS GET IN CONTACT WITH THE PATIENT AND WERE REMOVED BY THE USE OF FORCEPS. THERE WAS A BACK-UP DEVICE USED. THERE WAS NO PATIENT IMPACT. A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE TIP WAS BROKEN-DETACHED ABOUT 5 MINUTES DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THERE WERE FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BUR. THE FRAGMENTS GET IN CONTACT WITH THE PATIENT AND WERE REMOVED BY THE USE OF FORCEPS. THERE WAS A BACK-UP DEVICE USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831989 ↗
• MalfunctionOct 16, 2018Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE INNER BLADE BROKE OFF WITHIN 5 MINUTE S OF USE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THERE WAS A 15-20 MINUTE DELAY IN RETRIEVING THE FRAGMENTS OF THE TIP OF THE BLADE IN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER BLADE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969320 ↗