AxiumTM FC-4-8-3DRecalls & reported problems
Micro Therapeutics, Inc. · FRAMING COIL FC-4-8-3D 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 00847536022898), received between Aug 20, 2018 and Aug 20, 2018 — 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.
MalfunctionAug 20, 2018Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITHOUT THE INSTANT DETACHER 3 TIMES, AND MANUALLY 2 TIMES. THEY DID NOT ATTEMPT TO DETACH IT WITH ANOTHER INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, A-COM ANEURYSM WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 4.5MM. THE VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7798651 ↗
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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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