Tricut 1884004HRRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884004HR TRICUT 5PK M4 4MM ROTATE · Class 1
All models of Tricut (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000543918), received between Feb 11, 2022 and Jan 29, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Fragmentation1
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE OP, THE BLADE KEPT SHAKING WHEN ROTATING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21262241 ↗MalfunctionSep 19, 2024Break; Break
IT WAS REPORTED THAT PRIOR TO USE, THE BLADE WAS SNAPPED. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20253729 ↗InjuryNov 28, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING PROCEDURE, SHARDS OF METAL BLADE CAME OFF THE BURR INSIDE THE PATIENT'S NASAL CAVITY. THE SHARDS OF METAL WERE IRRIGATED OUT OF THE PATIENT¿S NOSE BY THE SURGEON. THE BURR WAS REMOVED FROM THE STERILE FIELD AND NEW STERILE BLADE WAS GIVEN TO COMPLETE THE PROCEDURE. THERE WERE 5-10 MINUTES DELAY IN PROCEDURE. THERE WAS NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18214617 ↗MalfunctionJul 11, 2023Break; Break
IT WAS REPORTED THAT DURING PROCEDURE WHEN SURGEON WAS USING BLADE IT BROKE AND FELL OUT. IT WAS FURTHER REPORTED THAT THE BLADE ITSELF FELL OUT AND IT WAS REMOVED WITH THE FORCEPS. NO FRAGMENTS REMAIN IN THE PATIENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300272 ↗MalfunctionFeb 11, 2022Break; Break
INFORMATION WAS RECEIVED FROM HCP. SURGEON TESTED MICRODEBRIDER BEFORE USE AND FOUND THE METAL TIP OF TRICUT BLADE HAD SNAPPED OFF AND LEAVING A SHARP EDGE. THE BLADE TIP WAS FOUND IN THE QUIVER. NO HARM TO THE PATIENT. NO BROKEN PIECE OF DEVICE REMAINS IN PATIENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13511541 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1882936EMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- N/A 1884033Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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