Axium Detachable Coil System QC-1.5-4-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037243), received between Jul 22, 2024 and Jan 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE FAILURE TO DETACH WERE REPEATEDLY USING THE BACKUP DETACHMENT, FOUND THAT IT COULD NOT BE DETACHED. THE CAUSE OF THE FAILURE TO DETACH WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066166 ↗
• MalfunctionJul 22, 2024Inadequacy of Device Shape and/or Size; Stretched; Unintended Movement; Migration; Inadequacy of Device Shape and/or Size; Stretched; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED THAT THE COIL "FLOATED INTO THE BLOOD VESSEL MEANT THAT THE COIL HAD MIGRATED INTO THE PARENT ARTERY AFTER BEING STRETCHED. THE COIL DID NOT PREMATURELY DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790705 ↗

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