Axium QC-8-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462010420), received between Jul 17, 2018 and Mar 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 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.

• MalfunctionMar 29, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL BECAME STUCK IN THE CENTRAL PART OF THE MICROCATHETER, AND EARLY DETACHMENT WAS A CONCERN. THE COIL WAS RETRIEVED AND REPLACED. THERE WAS NO DAMAGE NOTED TO THE CATHETER. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS SAID TO NOT BE INVOLVED IN THE EVENT. ANCILLARY DEVICES INCLUDE A SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584819 ↗
• MalfunctionJul 17, 2018Separation Failure; Activation, Positioning or Separation Problem; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED TO DETACH THE COIL WITH AN INSTANT DETACHER BUT IT WOULD NOT DETACH. A MANUAL DETACHMENT WAS THEN ATTEMPTED BUT THE COIL REMAINED UNDETACHED. AS A RESULT THE COIL WAS REMOVED FROM THE PATIENT AND A NEW DEVICE USED TO COMPLETE THE SURGERY. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY TO TREAT A 14MM CEREBRAL ANEURYSM. AS A RESULT OF THE ISSUE THE PROCEDURE WAS EXTENDED LESS THAN 30 MINUTES. IT WAS NOTED THAT THERE WERE 3 COILS IMPLANTED USING THE SAME MICROCATHETER PRIOR TO THE ISSUE AND NO ABNORMALITIES WERE SEEN. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7693780 ↗

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