AxiumTM FC-4-12-3DRecalls & reported problems
Micro Therapeutics, Inc. · FRAMING COIL FC-4-12-3D V01 · Class 2 · Implant
All models of AxiumTM (139)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536022911), received between May 4, 2021 and May 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
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.
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2021Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER WHICH WAS USED SUCCESSFULLY WITHOUT ISSUE WITH ANOTHER COIL. NO OTHER ISSUES OCCURRED PRIOR TO THE COIL NON-DETACHMENT. NO DAMAGE TO THE COIL PUSHWIRE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11772934 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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