Axium QC-14-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010222), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 malfunction.

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

• MalfunctionJan 29, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 12.2MM X 9.6MM LOCATED IN THE CAVERNOUS SINUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VASCULATURE WAS NORMAL IN TORTUOSITY. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE AXIUM COIL WAS FOUND TO BE ACCIDENTALLY DETACHED. THERE WAS REPORTEDLY NO DAMAGE OR STRETCHING TO THE COIL. NO UNUSUAL RESISTANCE WAS NOTED DURING DELIVERY. THE COIL WAS REPLACED WITH A COIL. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9645024 ↗

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