Fusion® Tricut® 1884080EMRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884080EM TRICUT 4MMX13CM M4 ROHS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000033842), received between Jun 14, 2020 and Jun 14, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- Aug 31, 2021Class IIOpen, Classified
There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0157-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Jam2
- Vibration2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2020Vibration; Mechanical Jam; Vibration; Mechanical Jam
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADES WERE NOT ROTATING PROPERLY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE DEFECTIVE BLADE WAS REPLACED WITH ANOTHER BLADE, WHICH WAS ALSO DEFECTIVE. THE INNER CANNULA WAS NOT ROTATING PROPERLY AND THE BLADE VIBRATED IN AN UNUSUAL MANNER WHILE BEING USED ON THE PATIENT. IT WAS BEING USED FOR THE FIRST TIME TO DEBRIDE SINUS TISSUE. THE SURGEON WAS ABLE TO COMPLETE SURGERY WITH OTHER DEVICE. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO TROUBLESHOOT AFTER THE CASE WITH THE DEFECTIVE BLADES AND A NEW BLADE AND DETERMINED THAT THE BLADES USED WERE DEFECTIVE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10151447 ↗MalfunctionJun 14, 2020Vibration; Mechanical Jam; Vibration; Mechanical Jam
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADES WERE NOT ROTATING PROPERLY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE DEFECTIVE BLADE WAS REPLACED WITH ANOTHER BLADE, WHICH WAS ALSO DEFECTIVE. THE INNER CANNULA WAS NOT ROTATING PROPERLY AND THE BLADE VIBRATED IN AN UNUSUAL MANNER WHILE BEING USED ON THE PATIENT. IT WAS BEING USED FOR THE FIRST TIME TO DEBRIDE SINUS TISSUE. THE SURGEON WAS ABLE TO COMPLETE SURGERY WITH OTHER DEVICE. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO TROUBLESHOOT AFTER THE CASE WITH THE DEFECTIVE BLADES AND A NEW BLADE AND DETERMINED THAT THE BLADES USED WERE DEFECTIVE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10151436 ↗
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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 · each recall links to the FDA recall notice
- 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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