TricutRecalls & reported problems across all models
Medtronic Xomed, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Tricut model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 150
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 17 models of Tricut by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2017 and Sep 28, 2026 — classified as 10 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Break” (59 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tricut recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2021Open, Classified
There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0156-2022 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
Most reported Tricut problems
Device problems
- Break59
- Material Fragmentation42
- Vibration33
- Material Separation26
- Mechanical Jam7
- Noise, Audible3
- Physical Resistance/Sticking3
- Failure to Cut2
Patient problems
- No Consequences Or Impact To Patient68
- No Clinical Signs, Symptoms or Conditions66
- No Known Impact Or Consequence To Patient9
- Radiation Exposure, Unintended4
- Unintended Radiation Exposure3
- No Patient Involvement2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Tricut models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tricut® 1884030HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884031HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884020BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884004BUR, EAR, NOSE AND THROAT46 reports
- Tricut 1884004BUR, EAR, NOSE AND THROAT40 reports
- Tricut® 1884004HRBUR, EAR, NOSE AND THROAT36 reports
- Tricut® 1883504HRBUR, EAR, NOSE AND THROAT8 reports
- Tricut 1884004HRBUR, EAR, NOSE AND THROAT5 reports
- Tricut® 1883504BUR, EAR, NOSE AND THROAT3 reports
- Tricut 1883504BUR, EAR, NOSE AND THROAT3 reports
- Tricut® 1882904BUR, EAR, NOSE AND THROAT2 reports
- Tricut® 1884030BUR, EAR, NOSE AND THROAT2 reports
- Tricut 1884080HRBUR, EAR, NOSE AND THROAT2 reports
- Tricut 1882904HREBUR, EAR, NOSE AND THROAT1 report
- Tricut® 1884031BUR, EAR, NOSE AND THROAT1 report
- Tricut 1883504HRBUR, EAR, NOSE AND THROAT1 report
Recent Tricut adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 4, 2025Break; Break
ADDITIONAL INFORMATION STATES THAT ADDITIONAL OR TIME NEEDED TO RETRIEVE THE AIRWAY FOREIGN BODY.
Patient problems: Insufficient Information
MAUDE report 22402818 ↗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 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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