Axium PrimeTM FC-25-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034488), received between Jul 31, 2022 and Jul 31, 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE FRAMING COIL WAS THE FIRST TO BE USED IN THE PROCEDURE. THE COIL HAD RESISTANCE AND BECAME STUCK IN THE ECHELON MICROCATHETER. THE SURGEON REMOVED THE SYSTEM. THERE WAS NO DAMAGE NOTED TO THE CATHETER BUT THE COIL WAS OBSERVED TO BE DAMAGED. THE PATIENT VESSEL WAS RE-ACCESSED AND THE REPLACEMENT COILS WERE DELIVERED AND DETACHED WITHOUT ISSUE. IT WAS NOTED THE FRAMING COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THE CATHETER WAS FLUSHED CONTINUOUSLY PER IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT UNSPECIFIED NEUROVASCULAR ABNORMALITIES. ADDITIONAL INFORMATION WAS RECEIVED. THE RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136938 ↗