Axium PrimeTM FC-12-40-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL FC-12-40-3D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034372), received between Aug 12, 2022 and Aug 12, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THREE COILS PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY SIPHON. THE MAX DIAMETER WAS 12.3MM, AND THE NECK DIAMETER WAS 8.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS A LOT OF RESISTANCE WHEN THE SPRING COIL (FC-12-40-3D) WAS PUSHED FROM THE PROTECTIVE SHEATH INTO THE MICROCATHETER. THE SURGEON WITHDREW THE DELIVERY GUIDE WIRE AND PLANNED TO TAKE OUT PART OF THE SPRING COIL FOR OBSERVATION. AFTER THE DELIVERY GUIDE WIRE WAS WITHDRAWN FROM THE MICROCATHETER, IT WAS FOUND THAT IT WAS DETACHED AND THE COIL BODY REMAINED IN THE MICROCATHETER. THE COIL WAS REMOVED WITHOUT FURTHER INTERVENTION. THE PUSHWIRE WAS NOT BENT/BROKEN, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENTS HAD BEEN MADE, AND THE DELIVERY PUSHER WAS NOT ROTATED. DURING THE PROCESS OF FILLING THE ANEURYSM WITH ANOTHER SPRING COIL (FC-8-20-3D), THE SURGEON TRIED TO ADJUST THE POSITION OF THE SPRING COIL INTO THE LOOP. DURING ADJUSTMENT, IT WAS FOUND THAT THE SPRING COIL WAS DETACHED. AT THIS TIME, PART OF THE SPRING COI
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15217994 ↗
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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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