Axium PrimeTM APB-1-3-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-1-3-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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032101), received between Aug 9, 2021 and Aug 25, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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
- Incomplete or Missing Packaging1
- Material Deformation1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2021Incomplete or Missing Packaging; Material Deformation; Incomplete or Missing Packaging; Material Deformation
ADDITIONAL INFORMATION RECEIVED REPORTED ONLY 2 OF THE 4 COILS WERE RETURNED FOR ANALYSIS. THE OTHER TWO COILS COULD BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367893 ↗MalfunctionAug 9, 2021Stretched; Stretched
MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STRETCHED. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO OTHER ISSUES NOTED DURING THE PROCEDURE THAT MAY HAVE RESULTED IN THE DAMAGE FOUND. THE COIL WAS STRETCHED DURING DELIVERY. ANCILLARY DEVICE: ECHELON 10 MICROCATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12292285 ↗
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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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