Axium PrimeTM APB-3-6-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-3-6-HX-ES V04 · 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 00847536032262), received between Apr 7, 2021 and Jun 21, 2021 — 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
- Separation Failure1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN ADJUSTING THE COIL DURING THE OPERATION, IT WAS FOUND THAT IT COULD NOT BE WITHDRAWN AND WAS DETACHED IN THE MICROCATHETER. SINCE THE COIL WAS UNABLE TO BE WITHDRAWN, THEY CONTINUED TO PUSH IT OUT OF THE MICROCATHETER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12032311 ↗MalfunctionApr 7, 2021Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED INDICATED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND THERE WAS NO DAMAGE TO THE PUSHWIRE OBSERVED AFTER REMOVAL. THE PATIENT INFORMATION, LESION CHARACTERISTICS, AND INSTANT DETACHER LOT # WERE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628776 ↗
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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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