Axium Detachable Coil System QC-12-40-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037533), received between Oct 18, 2022 and Nov 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE DISTAL PART OF THE COIL WAS STUCK, AND WHEN THEY TRIED TO PULL IT OFF THE COIL WAS DAMAGED. THE COIL WAS ELONGATED. NO DETACHMENT ATTEMPTS WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727959 ↗
• MalfunctionOct 18, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT MECHANICAL DETACHMENT METHOD WAS USED TO BREAK OFF AT THE DETACHMENT MARK AT THE END OF THE COIL PUSH ROD. THE SURGEON REPORTED THAT THE SURGERY WENT WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626206 ↗

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