Axium PrimeTM FC-5-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034198), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 22, 2021Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM FRAMING COIL THAT WAS DAMAGED DURING A PROCEDURE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY M2 SEGMENT. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IN THE PROCESS OF FORMING THE HOOP, THE COIL COIL NOT BE PUSHED IN. THE PHYSICIAN INTENDED TO REPOSITION THE COIL BUT IN THE PROCESS OF WITHDRAWING THE COIL, IT WAS NOTED TO BE DAMAGED IN THE MIDDLE SECTION WITHIN MICROCATHETER. THE COIL WAS REMOVED AND REPLACED WITH AN AXIUM FRAMING COIL OF A DIFFERENT SIZE WHICH WAS USED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE SPRING COIL BROKE INTO 2 SEPARATE PIECES. NO ISSUES WERE FOUND TO HAVE RESULTED FROM THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513688 ↗