Axium PrimeTM APB-3.5-6-3D-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-3.5-6-3D-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 00847536031951), received between Feb 22, 2021 and Feb 22, 2021 — classified as 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
- 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.
MalfunctionFeb 22, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED WITHIN THE MICROCATHETER AFTER FAILED DETACHMENT ATTEMPTS. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A C6 SEGMENT. THE ANEURYSM MAX DIAMETER WAS 5.3MM AND THE NECK DIAMETER WAS 3.9. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE COIL WAS D ELIVERED SUCCESSFULLY BUT COULD NOT BE DETACHED WITH THE FIRST ATTEMPT, USING THE INSTANT DETACHER. MANUAL DETACHMENT WAS THEN ATTEMPTED ONCE BUT ALSO FAILED. SINCE THE COIL FAILED TO DETACH, IT WAS WITHDRAWN. WHILE WITHDRAWING, THE COIL DETACHED WITHIN THE MICROC ATHETER. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE AXIUM COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS, INJURY, OR COMPLICATIONS ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11357779 ↗
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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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