Axium QC-18-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00836462010512), received between Feb 28, 2020 and Nov 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE FIRST COIL PREMATURELY DETACHED AND THE PUSHWIRE SEPARATED. CONTRADICTORILY, IT WAS STATED THAT THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE OF EITHER COIL. THE COIL MANAGED TO BE PLACED, BUT IT WAS UNKNOWN IF IT WAS IN THE INTENDED PLACE. THE FIRST COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, BUT THE SECOND COIL WAS STUCK. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COILS WERE PULLED BACK INSIDE DURING HYDRATION. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT HAD BEEN UNDERGOING TREATMENT FOR A BASILAR TIP ANEURYSM, WHICH WAS MORE THAN 20MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792501 ↗
• MalfunctionJan 7, 2021Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS NOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11136281 ↗
• MalfunctionFeb 28, 2020Stretched; Separation Failure; Physical Resistance/Sticking; Stretched; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 3-4 TIMES WITH USING INSTANT DETACHER AND 1 TIME WITH USING MANUAL DETACHMENT METHOD BUT COIL DID NOT DETACH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9769559 ↗

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-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
• 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