Axium QC-25-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462010543), received between Mar 15, 2017 and Jul 11, 2021 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS EXPOSED TO SALINE SOLUTION DURING PREPARATION, AND THE COIL WAS DETACHED. THERE WAS NO DAMAGE TO THE PUSHWIRE OBSERVED, AND NO DETACHMENT ATTEMPTS WERE MADE. A REPLACEMENT DEVICE WAS USED IN THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT. ANCILLARY DEVICES INCLUDE A PHENOM 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148303 ↗
• MalfunctionAug 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT, SECOND COIL GOT STRETCH. THIRD COIL STUCK IN THE CATHETER AND DETACH INSIDE THE ECHELON CATHETER. THE PATIENT UNDERWENT COILING TREATMENT FOR VEIN OF GALLEN. IT WAS REPORTED THAT PATIENT PRESENTED WITH A VEIN OF GALLEN MALFORMATION IN THE BRAIN. LEFT VERTEBRAL WAS CATHETERIZED WITH 5F NEU RON. ECHELON 10 WAS TAKEN INTO THE FISTULA SAC OVER THE TRAXCESS WIRE. ONCE ECHELON WAS PLACED INTO THE SAC, FIRST COIL AXIUM 25X50 WAS TAKEN TO DEPLOY INTO THE SAC. WHILE PUSHING AXIUM 25X50 THROUGH THE ECHELON THERE WAS A LOT A RESISTANCE IN THE DISTAL END OF THE MICROCATHETER AND COIL WAS NOT COMING OUT OF THE MICROCATHETER. THE COIL WAS NOT DAMAGED. THEN PHYSICIAN HAD TAKEN OUT THAT COIL AND REPLACED WITH SECOND COIL OF AXIUM 20X50. AFTER DEPLOYING AXIUM 20X50 WHEN PHYSICIAN TRIED TO REPOSITION THE COIL THE COIL GOT STRETCHED AND HAD TO REMOVE THE COIL. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL ONLY ONE TIME. THEN PHYSICIAN TOOK THIRD COIL OF AXIUM 25X50 AND TRIED DEPLOYING THROUGH THE ECHELON. WHILE DEPLOYING THERE WAS A LOT OF RESISTANCE IN ECHELON AND COIL GOT DETACHE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8880178 ↗
• DeathJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN REPORTED THAT HE DID NOT BELIEVE THE EVENT WAS THE FAULT OF THE PRODUCT AND FELT THAT THE EVENT WAS MORE DUE TO THE COMPLEXITY OF THE CASE.

  Patient problems: Death

  MAUDE report 8273992 ↗
• MalfunctionMar 15, 2017Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF AN ANEURYSM LOCATED IN THE CAVERNOUS SINUS, THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER. IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO DETACH THE COIL 3 TIMES WITH THE INSTANT DETACHER. THE PHYSICIAN REMOVED THE DEVICE AND FOUND THE COIL TO BE STRETCHED. A NEW DEVICE WAS USED TO COMPLETE THE TREATMENT SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6406358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab