Axium PrimeTM APB-2-3-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-2-3-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 00847536032170), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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
- Stretched1
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 3, 2022Stretched; Stretched
MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DELIVERED TO THE MICROCATHETER AND THE COIL WAS FOUND TO BE STRETCHED UNDER THE IMAGE. THE COIL WAS REPLACED AND THE OPERATION WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 3MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO DAMAGES TO THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13434946 ↗
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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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