Tricut 1884004Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 20763000543840), received between Sep 6, 2023 and Sep 28, 2026 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Vibration” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Vibration

  It was reported that prior to use, the blade was not rotating, and the inner blade was bent. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911082 ↗
• MalfunctionSep 25, 2026Vibration

  It was reported that during intra-op, the blade was installed but could not cut. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893973 ↗
• MalfunctionJun 16, 2026Vibration

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE WAS VIBRATING VERY BADLY ON THE HANDPIECE, AND IT DOESN¿T SOUND NORMAL. AFTER CHANGING THE BLADE, THE OTHER BLADE SEEMS TO CUT PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513989 ↗
• MalfunctionDec 1, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING PRE-OP NO DAMAGE NOTICED ON THE PRODUCT PACKAGE. THE TWO STRAIGHT BLADES WERE REPORTED TO BE NON-ROTATING BECAUSE THE INNER AND OUTER BLADES WERE FIXED TOGETHER, PREVENTING ROTATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677669 ↗
• MalfunctionDec 1, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING PRE-OP NO DAMAGE NOTICED ON THE PRODUCT PACKAGE. THE TWO STRAIGHT BLADES WERE REPORTED TO BE NON-ROTATING BECAUSE THE INNER AND OUTER BLADES WERE FIXED TOGETHER, PREVENTING ROTATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677657 ↗
• MalfunctionNov 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT INTRAOPERATIVE, WHEN BLADE WAS CONNECTED TO THE HANDPIECE, THE BLADE DID NOT ROTATE. AFTER REPLACING IT WITH A NEW BLADE, IT COULD BE USED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677461 ↗
• MalfunctionNov 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, THE BLADE WAS REMOVED FROM THE BOX AND CONNECT TO THE HANDPIECE. THEY FOUNDED THAT THE BLADE WAS NOT RUNNING NORMALLY. THE BLADE WAS WOBBLING AND THERE WAS 5 MINUTES DELAY IN THE PROCEDURE. THEY USED BACKUP PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. HANDPIECE WHEN CONNECTED WITH OTHER BLADE WORKED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507719 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE PATIENT UNDERWENT BILATERAL SINUS SURGERY UNDER NASAL ENDOSCOPY. DURING THE PROCEDURE, ADDITIONAL INFORMATION RECEIVED THAT THE BLADE WAS COMPLETELY BROKEN WHEN VIEWED FROM THE OUTSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388205 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SINUS SURGERY TWO BLADES BROKEN AND DETACHED FROM HUB REGION. PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931571 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SINUS SURGERY TWO BLADES BROKEN AND DETACHED FROM HUB REGION. PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931503 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SINUS SURGERY BLADE BROKEN AND DETACHED FROM HUB REGION. PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931466 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT INNER SHAFT OF BLADE WAS BROKEN FOUND WHEN UNPACKING THE PRODUCT DURING THE PROCEDURE. THE REPORTED EVENT RESULT IN A PROCEDURE DELAYED BY 2 MINUTES. THE BLADE WAS BROKEN INTO TWO PIECE ONLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167869 ↗
• MalfunctionMay 30, 2025Mechanical Jam; Mechanical Jam

  IT REPORTED THAT, DURING INTRA OPERATIVE, STRAIGHT BLADE WAS CONNECTED TO THE M5. WHEN THE PEDAL WAS PRESSED, THE BLADE DID NOT TURN. WHEN THE BLADE WAS UNPLUGGED, THE INNER AND OUTER BLADES WERE FIXED TOGETHER, MAKING IT IMPOSSIBLE TO ROTATE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116253 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING INTRA OP THE BLADE BROKE AFTER FEW MINUTES OF OPERATION. THE BLADE BROKE INTO TWO PIECES AND NO FRAGMENTS DETACHED FROM HANDPIECE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033808 ↗
• MalfunctionMay 16, 2025Vibration; Vibration

  IT WAS REPORTED THAT, AT THE INTRA OPERATIVE, WHEN CONNECTING THE BLADE, THE STRAIGHT BLADE WAS THAT THE INNER AND OUTER BLADES WERE STUCK TOGETHER, WHICH MADE IT IMPOSSIBLE TO ROTATE WHEN THE BLADE WAS CONNECTED AND THE FOOT PEDAL WAS PRESSED, AND IT DID NOT AFFECT THE SURGERY. THE PROBLEM WAS SOLVED BY REPLACING THE BLADE. THE BLADE WAS WOBBLING DURING ANALYSIS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033203 ↗
• MalfunctionApr 25, 2025Vibration; Failure to Cut; Vibration; Failure to Cut

  IT WAS REPORTED THAT DURING PROCEDURE, THE BLADE COULD NOT CUT. THE BLADE WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT WHEN FIRST CONNECTED IT, TRIED IT FOR A FEW SECONDS AND IT WAS ABLE TO ROTATE. BUT DURING THE OPERATION, IT COULDN'T ROTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906299 ↗
• MalfunctionApr 25, 2025Vibration; Failure to Cut; Vibration; Failure to Cut

  IT WAS REPORTED THAT DURING PROCEDURE, THE BLADE COULD NOT CUT. THE BLADE WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT WHEN FIRST CONNECTED IT, TRIED IT FOR A FEW SECONDS AND IT WAS ABLE TO ROTATE. BUT DURING THE OPERATION, IT COULDN'T ROTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906277 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT VENT TUBE MISSING AND BLADE DAMAGED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898959 ↗
• MalfunctionMar 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, BEFORE THE PROCEDURE, THE INNER AND OUTER BLADES WERE CONNECTED TOGETHER AND COULDN'T ROTATE. THE HANDPIECE WAS WORKING FINE WITH OTHER BLADES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728535 ↗
• MalfunctionFeb 24, 2025Vibration; Physical Resistance/Sticking; Vibration; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING ENDOSCOPIC NASAL POLYPECTOMY PROCEDURE, AFTER THE BLADE WAS CONNECTED TO THE HANDPIECE, STEPPED ON THE PEDAL AND IT WAS FOUND THAT THE ROTATIONAL SPEED WAS LOW AND ABNORMAL. AFTER INSPECTION, IT WAS FOUND THAT THERE WAS FRICTION BETWEEN THE INNER AND OUTER BLADES OF THE BLADE, WHICH WAS NOT FLEXIBLE AND CAUSED THE ROTATION SPEED TO BE VERY SLOW. AFTER REPLACING IT WITH A NEW BLADE, THE ROTATION SPEED WAS NORMAL AND THE OPERATION CONTINUED. THERE WAS NO ALLEGATION WITH THE FOUR PACKS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442937 ↗
• MalfunctionFeb 20, 2025Vibration; Physical Resistance/Sticking; Vibration; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP, THE BLADE DID NOT ROTATE. THE BLADE COULD NOT BE USED WITH ANOTHER HANDPIECE, OTHER BLADES WITH THE SAME HANDPIECE COULD BE USED NORMALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418140 ↗
• MalfunctionFeb 19, 2025Vibration; Vibration

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO ALLEGATION AGAINST THE HANDPIECE, AND WHEN THEY TRIED A DIFFERENT BLADE WITH THE REPORTED HANDPIECE, NO ISSUE WAS OBSERVED WITH THE OTHER BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408592 ↗
• MalfunctionFeb 12, 2025Vibration; Connection Problem; Vibration; Connection Problem

  IT WAS REPORTED THAT WHEN THE BLADE WAS OPENED AND USED ON THE HANDPIECE OF M4, THE TIP WAS NOT MATCHED AND WAS NOT CONNECTING / NOT SEATING PROPERLY, COULD NOT BE INSERTED INTO THE PLANING DEVICE, AND COULD NOT BE USED. THERE WAS NO PATIENT IMPACT. AS PER THE ANALYSIS OF THE FAULTY BLADE AT LAB, WOBBLING ISSUE WAS OBSERVED DURING THE OSCILLATION OF THE BLADE. THE DISTAL END OF THE DEVICE/TIP WAS WOBBLING EXCESSIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361836 ↗
• MalfunctionFeb 11, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE USER OPENED A BLADE, WHICH IS USED ON THE HANDPIECE OF M4, INSERTED IT INTO THE HANDPIECE WITHOUT ROTATING. AFTER INSERTING INTO HANDPIECE IT WAS FOUND THAT BLADE WAS NOT ROTATING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ANALYSIS FOUND THAT DEVICE WAS WOBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353156 ↗
• MalfunctionFeb 10, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN THE USER OPENED A BLADE, WHICH IS USED ON THE HANDPIECE OF M4, THE BLADE STOPPED ROTATING AFTER A FEW ROTATION. THE HANDPIECE TESTED WITH ANOTHER BLADE AND IT WAS NORMAL TO CONNECT OTHER BLADES. THE BLADE ROTATED A FEW TIMES AND THEN STOPPED ROTATING. THE BLADE WAS USED FOR THE FIRST TIME AFTER OPENING FROM THE PACKAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344062 ↗