AxiumTM FC-5-15-3DRecalls & reported problems
Micro Therapeutics, Inc. · FRAMING COIL FC-5-15-3D 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 00847536022959), received between Mar 11, 2021 and Mar 11, 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.
MalfunctionMar 11, 2021Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER BUT WAS DETACHED WITH THE HYPOTUBE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE RIGHT SUPERIOR CEREBELLAR ARTERY. THE MAX DIAMETER WAS 6.7 MM. THE NECK DIAMETER WAS 2.3 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COIL WAS INTRODUCED AND FORMED IN THE ANEURYSM WITH NO ISSUE. UPON DETACHMENT, THE DETACHER WAS SLID OVER THE BACK OF THE PUSHER WIRE AND THE TRIGGER WAS PULLED PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN NOTICED MINIMAL MOVEMENT OF THE PROXIMAL PUSHER POST DETACHMENT. WHEN THEY PULLED BACK ON THE COIL, THE COIL WAS NOT DETACHED. THE PHYSICIAN THEN ATTEMPTED THE HYPOTUBE BREAK METHOD BUT WAS UNABLE TO PULL BACK ON THE RELEASE WIRE AND EXPERIENCED HIGH LEVEL OF FRICTION/RESISTANCE. AFTER SEVERAL ATTEMPTS TO DO THE HYPOTUBE BREAK METHOD, THEY WERE ABLE TO PULL BACK ON THE RELEASE WIRE AND THE COIL DETACHED AND WAS IMPLANTED. THEY PHYSICIAN HAD ATTEMPTED TO USE THE INSTANT DETACHER (ID) TWICE, AND ONLY ONE ID WAS USED. THE MANUAL METHOD WAS ATTEMPTED TO 3-4 TIMES. THE PATIENT DID
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11468219 ↗
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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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