Fusion® 1884012EMRecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1884012EM RAD12 4MM M4 ROTATE ROHS · Class 2
All models of Fusion (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994617415), received between Apr 27, 2017 and Feb 10, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Device problems
- Break4
- Material Fragmentation3
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT DURING FESS SURGERY, CONNECTION FROM THE BLADE IS BROKEN NEAR THE HUB. THERE WAS NO INTERVENTION PERFORMED / PLANNED. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13504806 ↗MalfunctionNov 17, 2017Break; Material Fragmentation; Break; Material Fragmentation
THE CUSTOMER REPORTED, DURING AN ETHMOIDECTOMY SURGERY, THE DISTAL PORTION OF THE BLADE BROKE OFF AND INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BLADE FRAGMENT WITHOUT ADDITIONAL EQUIPMENT. A SECOND BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7040764 ↗MalfunctionOct 2, 2017Material Fragmentation; Material Fragmentation
THE SALES REP REPORTED THAT INTRAOPERATIVE, THE RAD 12 BLADE TIP BROKE OFF WHILE SITE WAS CLEANING IT OVER THE BACK TABLE. THEY WERE ABLE TO COMPLETE THE SURGERY WITH OTHER INSTRUMENTS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6907753 ↗MalfunctionAug 2, 2017Break; Break
THE CUSTOMER REPORTED AN ISSUE WITH A RAD12 TRACKING BLADE. IT APPEARED THAT THE BLADE'S SPIRAL WRAP WAS DAMAGED. ADDITIONAL INFORMATION RECEIVED INDICATES THE SPIRAL WRAP EXTENSION DID NOT RESULT IN FRAGMENTS. HOWEVER, THE PRODUCT ANALYSIS INDICATES THE TIP OF THE SPIRAL WRAP WAS DETACHED. THERE WAS NO REPORTED PATIENT IMPACT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6761737 ↗MalfunctionJul 12, 2017Break; Break
THE CUSTOMER REPORTED THAT THE TIP OF THE BLADE BROKE DURING SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6709466 ↗MalfunctionApr 27, 2017Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE BLADE BROKE INTO THE PATIENT. THE SURGEON EASILY RETRIEVED THE BROKEN TIP FROM THE PATIENT, NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BUR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6526791 ↗
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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
- 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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