Axium QC-4-10-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010123), received between Mar 24, 2020 and Mar 24, 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.

• MalfunctionMar 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THE FIRST AXIUM COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE) DURING THE COILING TREATMENT OF ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 4-5 TIMES WITH USING INSTANT DETACHER AND 2 TIMES ATTEMPTED WITH MANUAL DETACHMENT. THE COIL FINALLY DETACHED INSIDE THE MEDTRONIC MICROCATHETER. IT WAS ALSO REPORTED THAT SECOND AXIUM COIL DETACHED PREMATURELY INSIDE THE MEDTRONIC MICROCATHETER. THIS SECOND COIL WAS NOT REPOSITIONED AND NOT ATTEMPTED TO BE DETACHED. THE PATIENT UNDERWENT COILING TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN INTERNAL CAROTID ARTERY (ICA). A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE VESSEL ANATOMY AND BLOOD FLOW WERE BOTH NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9876085 ↗

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