Axium PrimeTM APB-3-10-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-3-10-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
- 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 00847536032286), received between Jan 14, 2022 and Jan 14, 2022 — 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.
Most reported problems
Device problems
- Material Deformation1
- Physical Resistance/Sticking1
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.
MalfunctionJan 14, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION THAT THE COIL HAD A LARGE PUSH RESISTANCE AND COULD NOT BE PUSHED IN THE MICROCATHETER. COIL STUCK IN CATHETER. AFTER THE MICROCATHETER WAS WITHDRAWN, IT WAS FOUND THAT THE PUSH ROD HAD A CREASE IN THE PROXIMAL SEGMENT. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM WITH A MAX DIAMETER OF 5MM AND A NECK OF 4MM. VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE OCCURRED IN THE MIDDLE AND DISTAL SEGMENTS OF THE MICROCATHETER. THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. INFORMATION ABOUT THE CATHETER WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13259352 ↗
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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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