AxiumTM FC-8-15-3DRecalls & reported problems
Micro Therapeutics, Inc. · FRAMING COIL FC-8-15-3D 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 00847536023055), received between Jun 29, 2020 and Jun 29, 2020 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2020Separation Failure; Separation Failure
MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT ABLE TO DETACH DURING THE PROCEDURE. THE PATIENT UNDERWENT COILING TREATMENT FOR SMALL ANEURYSM, MEASURING 7.5MM X 11.5MM. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE COIL INTO ANEURYSM, TRIED TO DETACH MULTIPLE TIME WITH NO SUCCESS. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH TWO DIFFERENT INSTANT DETACHERS, BUT COIL DID NOT DETACH. THE PHYSICIAN DID NOT ATTEMPT WITH MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE PHYSICIAN THEN MOVED TO ANOTHER SAME SIZE COIL. THE REMAINING COILS DEPLOYED ON FIRST TRY. A TOTAL OF 5 COILS WERE DEPLOYED. A PIPELINE WAS DEPLOYED AFTER THE COILING OF THE LARGE RECURRENT ANEURYSM. NO PATIENT INJURY WAS REPORTED. THE COIL WAS PREPARED ACCORDING TO INSTRUCTION FOR USE (IFU). THE VESSEL OBSERVED MODERATELY TORTUOUS. YES, THERE WAS CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10208878 ↗
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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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