Tricut® 1884004HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 20885074079534), received between May 18, 2017 and Mar 19, 2024 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (21 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, BLADE COULD NOT BE INSERTED AND SECURED WITH HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT. DURING ANALYSIS BLADE WAS FOUND VIBRATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928334 ↗
• MalfunctionJul 2, 2021Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE ENDOSCOPIC SINUS SURGERY PROCEDURE, THE BLADE HEAD WAS RUSTING OUT AND THROWING METAL SHARDS INTO THE PATIENT¿S NOSE WHILE IN USE. THE TIP OF THE SINUS BUR BEGAN TO ERODE THROUGH AFTER A FEW MINUTES OF USING IT IN THE NOSE (@ 5,000 RPM). THE OUTER CANNULA WAS CORRODED AND CAUSING METAL SHARDS TO COME OFF OF IT. THE METAL SHARDS FROM THE TIP OF THE SINUS BUR WHERE SEEN IN THE SURGICAL FIELD AND THE SINUS BUR WAS QUICKLY REMOVED FROM THE PATIENT'S NOSE. THERE WERE NO CORROSIVE LIQUIDS NEAR THE SINUS BUR PREVIOUS TO USE. ANOTHER TRICUT BLADE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106636 ↗
• MalfunctionOct 3, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE TIP OF THE BLADE AND THE JAGGED PART OF THE INNER TUBE WERE BROKEN DURING THE ENDOSCOPIC SINUS SURGERY. THE PROCEDURE WAS FINISHED USING A BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151478 ↗
• MalfunctionAug 15, 2019Break; Material Fragmentation; Break; Material Fragmentation

  UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PART OF THE BLADE THAT BROKE WAS THE TIP AND THERE WERE FRAGMENTS FROM THE DEVICE AND NONE LEFT INSIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896270 ↗
• MalfunctionJun 5, 2019Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A DISTRIBUTOR THAT THE TIP OF THE BLADE INNER CYLINDER WAS BROKEN DURING AN ENDOSCOPIC SINUS SURGERY. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670257 ↗
• MalfunctionMay 8, 2019Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE END OF THE DRILL FELL OFF DURING A STANDARD ENDOSCOPIC SINUS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591698 ↗
• MalfunctionMay 6, 2019Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BLADE WOULD NOT VACUUM THE DEBRIS PROPERLY DURING THE PROCEDURE. WHEN THE BLADE WAS TAKEN OUT OF THE PATIENT, IT WAS CRACKED IN HALF. THE CRACKED PIECE DID FRAGMENT BUT THERE WAS NO PIECES LEFT IN THE PATIENT. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584204 ↗
• MalfunctionMay 6, 2019Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE ENGAGEMENT OF THE DEVICE TO THE BONE FAILED AND THAT THE TIP OF THE INNER TUBE WAS BROKEN DURING POLYPECTOMY ON AN ENDOSCOPIC SINUS SURGERY PROCEDURE. THE DEVICE WAS USED FOR THE FIRST TIME. THERE WAS NO DELAY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583983 ↗
• MalfunctionApr 11, 2019Material Separation; Material Separation

  THE BLADE WAS REPLACED BY ANOTHER DEVICE FROM THE SAME BATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503712 ↗
• MalfunctionApr 2, 2019Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE TIP OF THE BLADE BROKE OFF DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8473695 ↗
• MalfunctionDec 20, 2018Break; Material Separation; Break; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT AFTER ATTACHING THE TIP, THE OSCILLATION OF THE BLADE WAS SENSED WHEN THE DEVICE WAS ROTATED. AFTER THAT, THE BLADE WAS BROKEN WHEN THE DEVICE WAS ROTATED CONTINUOUSLY. THERE WAS NOTHING DROPPED INTO THE PATIENT'S BODY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8186152 ↗
• MalfunctionDec 6, 2018Material Separation; Material Separation

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE FELL OFF DURING TESTING BEFORE BEING USED ON THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AND NO BACK-UP BLADES WERE USED. THERE WERE NO ADDITIONAL NON-ROUTINE ACTIONS TO PREVENT PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8139465 ↗
• InjuryNov 9, 2018Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT A SMALL PIECE OF BLADE BROKE OFF INSIDE THE SHEATH INTO THE PATIENT DURING A SUBMUCOUS RESECTION PROCEDURE. A NEW BLADE WAS OPENED AND THE CASE WAS COMPLETED. THERE WAS DELAY IN THE PROCEDURE. THE MISSING PIECE WAS NOT LOCATED AFTER SEVERAL XRAYS. THE PATIENT IS FINE AND HAD NO ISSUES AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8055325 ↗
• MalfunctionJul 25, 2018Break

  IT WAS REPORTED THE TIP OF THE BLADE BROKE OFF OF THE SHAVER INSIDE THE PATIENT'S NOSE. THE PHYSICIAN REMOVED THE BROKEN PIECE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7721153 ↗
• MalfunctionMay 24, 2018Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER STATED THAT A TRI-CUT BLADE BROKE OFF INSIDE THE PATIENT¿S NOSE DURING A CASE. THEY WERE ABLE TO RETRIEVE THE DEBRIS FROM THE NOSE. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542196 ↗
• MalfunctionMay 24, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED ABOUT A TRICUT BLADE THAT FELL APART IN THE MIDDLE OF A MAXILLARY ANTROSTOMY PROCEDURE. IT WAS A NEW BLADE. THE PIECE WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539859 ↗
• MalfunctionMay 14, 2018Break; Break

  DURING A PROCEDURE THE TIP OF A TRICUT BLADE BROKE OFF IN THE PATIENT; THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT AFTER 20 MINUTES. A NEW BLADE WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7512891 ↗
• MalfunctionMay 10, 2018Break; Material Separation; Break; Material Separation

  A CUSTOMER REPORTED THAT A PIECE OF A TRI-CUT BLADE BROKE OFF INSIDE OF THE PATIENT'S SINUSES. WHEN THE SURGEON REMOVED A SUCTION CATHETER HE NOTICED A METAL PIECE STUCK TO THE TIP OF THE SUCTION CATHETER WHICH WAS BLOCKING SUCTION AIR FLOW. IT WAS THEN DISCOVERED THE METAL DISPOSABLE PIECE WAS THE TOP PORTION OF THE TRICIUT BLADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503975 ↗
• MalfunctionApr 11, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT INTRAOPERATIVELY, THE ANTERIOR SIDE (AT THE TIP) OF TWO TRICUT BLADES BROKE OFF AND WERE RETRIEVED. RETRIEVAL DID NOT REQUIRE ADDITIONAL EQUIPMENT AND DID NOT REQUIRE AN ADDITIONAL PROCEDURE. THE BLADES WERE USED AT 3,000 RPM. THERE WAS NO PATIENT INJURY. THIS REGULATORY REPORT IS FOR BLADE 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422961 ↗
• MalfunctionApr 11, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT INTEROPERATIVELY, THE ANTERIOR SIDE (AT THE TIP) OF TWO TRICUT BLADES BROKE OFF AND WERE RETRIEVED. RETRIEVAL DID NOT REQUIRE ADDITIONAL EQUIPMENT AND DID NOT REQUIRE AN ADDITIONAL PROCEDURE. THE BLADES WERE USED AT 3,000 RPM. THERE WAS NO PATIENT INJURY. THIS REGULATORY REPORT IS FOR BLADE 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422943 ↗
• MalfunctionMar 13, 2018Break; Break

  WHEN DOCTOR WAS USING THE TRICUT MICRODEBRIDER BLADE DURING A FESS SURGERY, THE BLADE TIP BROKE OFF AND WENT MISSING. THEY COULD NOT FIND IT AND HAD TO TAKE THE PATIENT TO RADIOLOGY UNDER GENERAL ANESTHESIA TO PERFORM AN X-RAY TO LOOK FOR IT. ONE OF THE STAFF FOUND IT ON THE FLOOR OF THE OPERATING ROOM. IT WAS NOT INSIDE THE PATIENT. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333473 ↗
• MalfunctionMar 1, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SHAVER HEAD (TIP) SNAPPED OFF DURING THE PROCEDURE. A REPLACEMENT SHAVER BLADE WAS USED UNTIL THE END OF THE SURGICAL PROCEDURE. THERE WAS NO IMPACT OR INJURY TO PATIENT OR STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308070 ↗
• MalfunctionFeb 27, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE TIP OF THE BLADE BROKE OFF ON APPROACH TO THE NASAL CAVITY. THERE WAS NO PATIENT INJURY AND THE BLADE AND BROKEN PIECE OF THE BLADE WERE REMOVED AND RECOVERED FROM THE SINUS CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300525 ↗
• MalfunctionNov 17, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER REPORTED THE BLADE TIP BROKE DURING AN ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT NO FRAGMENT(S) REMAINED IN THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040765 ↗
• MalfunctionOct 27, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE FACILITY REPORTED THAT THE TIP SPRUNG OPEN DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985975 ↗