AxiumTM FC-3-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536022836), received between Mar 7, 2019 and Mar 7, 2019 — classified as 1 malfunction.

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

• MalfunctionMar 7, 2019Separation Failure; Migration; Separation Failure; Migration

  MEDTRONIC RECEIVED REPORT THAT THE COIL WAS STUCK AT THE ECHELON 10-45 CATHETER HUB. THIS WAS CLARIFIED TO NOTE THAT THERE WAS A DETACHMENT FAILURE RESULTING IN THE PHYSICIAN ATTEMPTING TO REMOVE THE COIL, CAUSING THE COIL TO FLY AWAY DISTAL SUDDENLY. THE PHYSICIAN THEN RETRIEVED THE COIL USING A SOLITAIRE 4X20 USING A HEADWAY CATHETER. THE COIL WAS REPORTED TO HAVE EXITED THE SHEATH SMOOTHLY. NO PATIENT INJURY OCCURRED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ANCILLARY DEVICES WERE DISCARDED AT THE SITE. NO DAMAGE WAS NOTED ON THE DEVICES. THE COIL WAS HYDRATED AND THE CONTINUOUS FLUSH WAS USED. THE SHEATH WAS FIRMLY SEATED IN THE HUB. THE RHV WAS TIGHTENED AROUND THE INTRODUCER SHEATH. NO ADDITIONAL ECHELON INFORMATION IS KNOWN. COMPETITOR COILS WERE USED WITH THE ECHELON TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399463 ↗