Axium PrimeTM FC-3.5-6-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL FC-3.5-6-3D V03 · Class 2 · Implant
All models of Axium PrimeTM (66)
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 00847536034082), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- 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 29, 2024Separation Failure; Material Deformation; Separation Failure; Material Deformation
MEDTRONIC RECEIVED A REPORT THAT THREE COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED A2/PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COMPLEX STENT COIL, DISTAL ANATOMY THAT DID WAS NOT AMENABLE TO DUAL MICROCATHETER PLACEMENT. ATLAS STENT WAS DEPLOYED WITH NO COMPLICATION. DUE TO 1 MICROCATHETER BEING USED, THEY HAD TO RE-ACCESS THE ANEURYSM THROUGH THE STENT (NOT UNCOMMON). THEY ENCOUNTERED SOME RESISTANCE ON THE PROXIMAL TINES OF THE STENT WITH THE MICROCATHETER (017 MC, 014 WIRE). THE STENT DID SLIGHTLY MIGRATE PROXIMAL TO DISTAL BUT NOTHING THAT PREVENTED FROM CONTINUING. THEY CONTINUED TO HAVE DIFFICULTY GETTING THROUGH THE STENT TO THE ANEURYSM WITH MULTIPLE ATTEMPTS. ONCE THEY DID GET ACCESS, THE MICROCATHETER TIP WAS IN THE SMALLER OF THE 2 LOBES OF THE ANEURYSM. TRIED TO DEVIATE BUT THE MICROCATHETER HAD A WEIRD SHAPE. THE DECISION TO DELIVER THE FIRST COIL WAS MADE. THE FIRST COIL 3.5 X 6 FRAME WAS ABLE TO FORM PROPERLY AND FILL IN SPACES THAT THEY WANTED. THE DETACHER WAS USED PER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004252 ↗
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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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