AxiumTM QC-7-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536029644), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Stretched” (1 report).

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 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.

• InjuryDec 6, 2021Therapy Delivered to Incorrect Body Area; Stretched; Use of Device Problem; Therapy Delivered to Incorrect Body Area; Stretched; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A COIL WAS STRETCHED AND THE WIRE WAS CUT AND LEFT IN THE PATIENT'S BODY. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SACCULAR C6 SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 5MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE QC-7-30-HELIX COIL WAS SECOND COIL TO BE USED. THERE WAS NO FRICTION OR OTHER DIFFICULTY OBSERVED DURING TESTING OR DELIVERY OF THE COIL. THE SURGEON PERFORMED SEVERAL ADJUSTMENTS SUCH AS PUSHING AND PULLING THE COIL AFTER WHICH THE COIL WAS STRETCHED BUT NOT DETACHED. THE SURGEON WITHDREW THE SPRING WIRE AND THE CATHETER TOGETHER BUT THE DISTAL END OF THE COIL REMAINED CONNECTED WITH THE COIL IMPLANTED IN THE ANEURYSM AND COULD NOT BE WITHDRAWN COMPLETELY FROM THE PATIENT'S BODY. AT THE FEMORAL ARTERY ACCESS, THE SURGEON CUT THE STRETCHED SPRING WIRE SHORE AND PART OF THE WIRE STAYED IN THE PATIENT'S BODY. IT WAS NOTED THE LENGTH OF THE SPRING WIRE IN THE BODY EXTENDED APPROXIMATELY FROM THE ANEURYSM TO THE FEMORAL ARTERY PUNCTURE SITE. SUBSEQUENTLY, THE SURGEON IMPLANTED A SOLITAIRE STENT TO PREVENT THE WIRE FROM FLOATING EXC

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12936478 ↗

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