Axium PrimeTM FC-3.5-8-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL FC-3.5-8-3D V03 · Class 2 · Implant
All models of Axium PrimeTM (66)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034099), received between Jul 23, 2020 and Aug 1, 2022 — classified as 1 injury, 1 malfunction.
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
- Difficult or Delayed Positioning1
- Physical Resistance/Sticking1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2022Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS SUCCESSFULLY PLACED IN THE ANEURYSM, BUT IT COULD NOT BE DETACHED. A REPLACEMENT COIL WAS ABLE TO BE USED SMOOTHLY. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15139532 ↗InjuryJul 23, 2020Difficult or Delayed Positioning; Detachment of Device or Device Component; Physical Resistance/Sticking; Difficult or Delayed Positioning; Detachment of Device or Device Component; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS DIFFICULTY POSITIONING THE COILS AND POOR FRAMING. THERE WAS NO RESISTANCE OR FRICTION WHEN THE PHYSICIAN PULLED THE COIL OUT, AND NO KINK/DAMAGE WAS OBSERVED ON THE PUSHWIRE. IT WAS UNKNOWN IF THE PATIENT WAS CURRENTLY SYMPTOMATIC.
Patient problems: Thrombus
MAUDE report 10316899 ↗
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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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