Tricut® 1884004Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 20681490047450), received between Jan 6, 2017 and Mar 18, 2025 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING ESS PROCEDURE, DEVICE WAS MALFUNCTIONING (SOME DISCOMFORT IN MOVEMENT). THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630258 ↗
• MalfunctionFeb 6, 2025Vibration; Mechanical Jam; Physical Resistance/Sticking; Vibration; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE OPERATION, AFTER THE BLADE WAS CONNECTED TO THE HANDLE, IT COULD NOT BE ROTATED NORMALLY, THE INTERFACE WAS NOT SMOOTH, AND IT WAS STUCK. THE BLADE WAS VIBRATING WHEN CONNECTED TO HANDPIECE AND IT WAS NOT USED ON PATIENT. CHECKED THAT THE HANDPIECE WAS NORMAL, AND IT COULD WORK NORMALLY WHEN REPLACING OTHER SAME-MODEL BLADE. A NEW BLADE WAS REPLACED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319480 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, SHE FOUND THAT THE BLADE HAD OBVIOUS SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT STILL HAD OBVIOUS SHAKE. FINALLY, THE DOCTOR DECIDED TO CHANGE A NEW BLADE TO PERFORM THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281393 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED THAT DURING ORBITOTOMY NASAL SINUS PROCEDURE, THEY BARELY STARTED USING THE SHAVER AND THE TIP BROKE INSIDE THE NOSE. THIS IS A METAL TIP THAT IS VERY DIFFICULT TO BREAK SO DEFECTIVE FROM THE START. DOCTOR COMMENTED THAT THEY USE MICRODEBRIDER DAILY. THIS IS NOT INCORRECT USE BY HIM. THE BROKEN PIECES WAS NO MORE INSIDE PATIENT BODY. NO INTERVENTION PERFORMED AND NO PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).  NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237303 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT DURING ETHMOIDECTOMY THE CUSTOMER STATED THAT THE BLADE HAS BROKEN SINCE THEY USE IT. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE COMPLETED WITH BACKUP DEVICE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152883 ↗
• MalfunctionDec 27, 2019Vibration; Vibration

  ON FOLLOW UP, IT WAS STATED THAT THE BLADE WAS MAKING A SOUND, LIKE IT WAS CATCHING AND GRINDING AGAINST THE INSIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9523080 ↗
• MalfunctionOct 2, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A BLADE WAS FRACTURED DURING THE PROCEDURE AND WAS COMPLETED USING A BACK UP PRODUCT. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144862 ↗
• MalfunctionSep 27, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT THE TIP OF THE BLADE BROKE OFF AND A FRAGMENT WAS DROPPED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) . THE DOCTOR REMOVED THE FRAGMENT FROM THE OPERATION AREA AND CHECKED THOROUGHLY TO MAKE SURE NO OTHER FRAGMENT WAS REMAINED IN THE OPERATION AREA. NO FRAGMENT OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THIS WAS THE INITIAL USE OF THE BLADE. THEN, THE DOCTOR CHANGED TO ANOTHER NEW BLADE TO COMPLETE THE SURGERY. THERE WAS A 10 MINUTE DELAY. THE SECOND HANDPIECE COULD FUNCTION PROPERLY WITH THE SAME HANDPIECE AND POWER SYSTEM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9128822 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT AFTER THE BLADE WAS USED FOR 30 MINUTES FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE TIP OF THIS BLADE GOT BROKEN. A FRAGMENT OF THE TIP DROPPED. THE DOCTOR REMOVED THE FRAGMENT FROM THE OPERATION AREA AND CHECKED THOROUGHLY TO MAKE SURE NO OTHER FRAGMENT WAS REMAINED IN THE OPERATION AREA. IT WAS THE INITIAL USE OF THE BLADE. THEN, THE DOCTOR CHANGED TO ANOTHER NEW BLADE TO COMPLETE THE SURGERY. THE SECOND DEVICE COULD FUNCTION PROPERLY WITH THE SAME HAND PIECE AND POWER SYSTEM. THE EVENT RESULTED TO 5-10 MINUTES OF DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117126 ↗
• InjuryAug 16, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A BILATERAL REDUCTION OF GYNAECOMASTIA USING LIPOSUCTION AND HANDPIECE. THE HANDPIECE WAS USED TO REMOVE THE GLANDULAR BREAST TISSUE. DURING THE PROCEDURE THE BLADE BROKE OFF AND HAD TO BE RETRIEVED WITH X-RAY AND EXTRA INCISION WAS MADE TO RETRIEVE THE BROKEN PART. THE PROCEDURE WAS DELAYED FOR FORTY FIVE MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8901268 ↗
• MalfunctionJun 17, 2019Material Separation; Material Separation

  ON FOLLOW-UP, IT WAS REPORTED THAT THE BREAK OF THE BLADE RESULTED IN A PORTION OF THE BLADE BEING DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703264 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DISSECTOR WAS BROKEN PRIOR TO A NOSE AND EYE RELATED ENDOSCOPIC MINIMALLY-INVASIVE SURGERY. IT WAS CONFIRMED THAT THERE WERE FRAGMENTS DETACHED FROM THE DEVICE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671810 ↗
• InjuryJun 3, 2019Material Separation; Vibration; Material Separation; Vibration

  A MANUFACTURER REPRESENTATIVE PRESENT DURING THE CASE REPORTED THAT THE SURGEON WAS PERFORMING AN ENDOSCOPIC SURGERY TO REMOVE POLYPS WHEN THE BLADE STARTED TO SHAKE AND REALIZED THAT THE INNER BLADE BROKE OFF. ANOTHER BLADE FROM THE SAME BATCH WAS USED AND THE EXACT SAME THING OCCURRED. ONE OF THE INNER BLADES WAS MISSING BUT INTRAOPERATIVE X-RAY CONFIRMATION VALIDATED THAT IT WAS NOT INSIDE THE PATIENT. IT WAS NOTED THAT THE OTHER TIP WAS FOUND. THE PROCEDURE WAS PERFORMED WITH THE THIRD BLADE AVAILABLE FROM THE SAME BATCH WHICH WORKED CORRECTLY. THERE WAS A 50-MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8664484 ↗
• InjuryJun 3, 2019Material Separation; Vibration; Material Separation; Vibration

  A MANUFACTURER REPRESENTATIVE PRESENT DURING THE CASE REPORTED THAT THE SURGEON WAS PERFORMING AN ENDOSCOPIC SURGERY TO REMOVE POLYPS WHEN THE BLADE STARTED TO SHAKE AND REALIZED THAT THE INNER BLADE BROKE OFF. ANOTHER BLADE FROM THE SAME BATCH WAS USED AND THE EXACT SAME THING OCCURRED. ONE OF THE INNER BLADES WAS MISSING BUT INTRAOPERATIVE X-RAY CONFIRMATION VALIDATED THAT IT WAS NOT INSIDE THE PATIENT. IT WAS NOTED THAT THE OTHER TIP WAS FOUND. THE PROCEDURE WAS PERFORMED WITH THE THIRD BLADE AVAILABLE FROM THE SAME BATCH WHICH WORKED CORRECTLY. THERE WAS A 50-MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8664475 ↗
• MalfunctionMay 28, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE INNER BLADE SHEARED OUT AND FELL INTO THE PATIENT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE LOOSE PIECE WAS RECOVERED AND THE SINUS WAS FLUSHED OUT TO ENSURE THAT ALL PIECES WERE RETRIEVED. THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY WITH THE PROCEDURE AND THE CASE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8648209 ↗
• MalfunctionMar 18, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A PIECE OF THE BLADE BROKE OFF. THERE WAS ABOUT 5 MINUTES DELAY IN THE PROCEDURE. THERE WAS NO TO VERY LITTLE IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428634 ↗
• MalfunctionFeb 27, 2019Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE QUICKLY BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374664 ↗
• MalfunctionFeb 20, 2019Break; Break

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS BROKEN WHEN THE LACRIMAL SAC WINDOW WAS OPENED TO REMOVE THE UNCINATE PROCESS DURING THE DACRYOCYSTORHINOSTOMY (DCR) PROCEDURE. THERE WAS A RISK OF FOREIGN MATTER REMAINING ON THE PATIENT. THERE WERE NO ADDITIONAL ACTIONS TAKEN TO PREVENT INJURY WITH THE BLADE. THERE WAS NO DELAY TO THE PROCEDURE AS A BACK-UP BLADE WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354488 ↗
• MalfunctionFeb 19, 2019Material Separation; Material Separation

  THE HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE WAS BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350987 ↗
• MalfunctionJan 23, 2019Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE BROKE OFF DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. ALL THE PIECES WERE RETRIEVED. THE PROCEDURE WAS DELAYED FOR 5 MINUTES TO ENSURE THAT ALL THE BROKEN PIECES WERE RECOVERED. A NEW BLADE WAS OPENED. THERE WAS NO ADDITIONAL, NON-ROUTINE ACTION TAKEN TO PREVENT INJURY. THERE WAS NO PATIENT IMPACT AND THAT THE PATIENT WAS DISCHARGED TO HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270123 ↗
• MalfunctionJan 22, 2019Break; Material Separation; Break; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE BASE OF THE BLADE BROKE AFTER ABOUT TEN (10) MINUTES INTO A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. ANOTHER BLADE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR LESS THAN 2 MINUTES. IT WAS THE INITIAL USE OF THE BLADE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266416 ↗
• MalfunctionDec 27, 2018Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING A ROUTINE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE SURGEON NOTICED THAT THE HANDPIECE DID NOT FEEL RIGHT SO THEY REMOVED THE BLADE FROM THE PATIENT AND NOTICED UPON CHECKING THE BLADE THAT THE TIP WAS MISSING. THEY CHECKED THE PATIENT FOR ANY SIGNS OF METALWORK OR INJURY (NONE DETECTED) AND UTILIZED A SECOND BLADE FROM A DIFFERENT BATCH TO COMPLETE THE CASE. THE MISSING TIP WAS FOUND ON THE DRAPES. THE HCP COMPARED THE TWO TIPS AND IT APPEARED TO HAVE ALL THE MISSING PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200775 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE TIP OF THE INNER TUBE GOT BROKEN AND DROPPED INSIDE PATIENT'S SINUS AFTER ABOUT 30 MINUTES INTO USE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE OSCILLATING RPM WAS ABOUT 5000RPM. THE HCP NOTED THAT IT WAS THE INITIAL USE OF THE BLADE. THE DOCTOR TOOK OUT THE BLADE AND ITS FRAGMENT AND THEN USED ANOTHER NEW BLADE TO COMPLETE THE SURGERY. THERE WAS NO PROBLEM WITH THE HANDPIECE BECAUSE IT COULD FUNCTION WELL WITH OTHER BLADES. THE SURGERY WAS DELAYED FOR 5 MINUTES. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8168849 ↗
• MalfunctionOct 22, 2018Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE BLADE WAS WOBBLY/UNSTABLE DURING PROCEDURE. BLADE WAS REPLACED WITH A NEW BLADE OF SAME LOT NUMBER AND IT WORKED PERFECTLY. CASE WAS CONTINUED AND COMPLETED WITH NO FURTHER INCIDENCE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991737 ↗
• MalfunctionSep 26, 2018Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE INNER BLADE BROKE INTO TWO PIECES DURING THE FU NCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7909476 ↗