Tricut® 1883504HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20885074080066), received between Jun 22, 2018 and May 27, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, WHILE USING THE TRICUT BLADE THE TIP BROKE OFF AND THE STAFF WERE ABLE TO RETRIEVE THE PIECE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400350 ↗
• MalfunctionJan 30, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT THE OUTER PART OF THE BLADE WAS LOOSE AND CAME COMPLETELY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604945 ↗
• MalfunctionJun 30, 2023Break; Break

  IT WAS REPORTED THAT THE BUR TIP WAS BROKEN. USER SEARCHED FOR ANY BROKEN PARTS IN THE NOSE AND MOUTH. NO BROKEN PARTS WERE FOUND INSIDE THE BODY. THE PHYSICIAN SAID, "IT MAY HAVE ALREADY BEEN SUCTIONED BY DEVICE," AND CONTINUED THE CASE. THERE WAS 10 MIN OF PROCEDURE DELAY.  THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. IMMEDIATELY AFTER USE, THERE WAS AN ABNORMAL NOISE FROM THE SHAVER. AS PER USER IT MIGHT BE A CLOG, THE SHAVER WAS UNCLOGGED, BUT THERE WAS NO CLOG. WHEN THE INNER TUBE WAS REMOVED, THE TIP WAS BROKEN. IT WAS REPLACED WITH ANOTHER LOT PRODUCT AND THE CASE WAS CONTINUED. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT BLADE BROKEN WHILE USING THE SHAVER AND THERE WAS FRAGMENTS. AFTER THE DAMAGE, THE PHYSICIAN CHECKED THE INSIDE OF THE NASAL CAVITY AND THE THROAT, BUT IT COULD NOT BE FOUND. USER ASSUMES THAT IT MIGHT HAVE BEEN SUCKED IN USING THE SUCTIONING DEVICE, THERE WAS NOTHINGS SEEM REMAINING IN THE PATIENT. THERE NO ANY FRAGMENTS REMAIN IN THE PATIENT, THE FRAGMENTS REMOVED BY USING THE SUCTIONING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236716 ↗
• MalfunctionDec 4, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BLADE TIP BROKE SOON AFTER THE OPERATION STARTED. THERE ARE NO RESIDUALS INSIDE THE PATIENT. NOT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912588 ↗
• MalfunctionJul 24, 2022Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING ESS PROCEDURE, THE THE ROTATION OF INNER CYLINDER IS POOR AND ITS STOPPED. UPON CHECKING, THE INNER CYLINDER WAS BROKEN AND COULD NOT BE USED ANYMORE. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH THE USED OF BACKUP PRODUCT(S). THERE WAS NO ANY REMAINING DAMAGED PIECE IN THE PATIENT'S BODY. THERE WAS ABOUT 10 MINUTES PROCEDURE EXTENSION DUE TO THE OCCURRENCE OF A DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090585 ↗
• MalfunctionJul 15, 2020Break; Break

  ON FOLLOW UP IT WAS DETERMINED THAT THE EVENT OCCURRED INTRA-OPERATIVELY. THERE WERE NO FRAGMENTS DETACHED FROM THE DEVICE. PROCEDURE DELAY WAS LESS THAN 30 MINS AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274596 ↗
• MalfunctionFeb 7, 2019Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE APART DURING THE PROCEDURE. THE INNER PORTION OF THE BLADE SEEMED TO HAVE SHEARED OFF DURING USE AFTER INITIALLY WORKING WELL. THE SHEARING RENDERED THE BLADE USELESS. THERE WAS NO PATIENT HARM SINCE ALL PIECES OF THE BLADE WERE ACCOUNTED FOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317536 ↗
• MalfunctionJun 22, 2018Material Fragmentation; Material Fragmentation

  DURING A PROCEDURE, THE TIP OF A TRICUT BLADE BROKE. THE DETACHED PIECE WAS RETRIEVED WITHOUT INTERVENTION OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629414 ↗