Axium Detachable Coil System QC-7-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037861), received between Dec 11, 2023 and May 19, 2026 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE AXIUM COIL PACKAGE AND PREPARING IT AS USUAL, A KINK WAS OBSERVED ON THE COIL PUSH ROD DURING DELIVERY. FOR PROCEDURAL SAFETY, ANOTHER COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER ANOTHER COIL WAS USED INSTEAD, DELIVERY WAS NORMAL AND THE PROCEDURE WAS SUCCESSFUL; THE MICROCATHETER HAD NO ISSUES. THERE WAS PUSHER KINK/BROKEN. A CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217835 ↗
• InjuryDec 11, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT ON NOVEMBER 19, 2023, THE PATIENT UNDERWENT INTERVENTIONAL SURGERY FOR A CEREBRAL ANEURYSM. WHEN THE CEREBRAL ANEURYSM WAS EMBOLIZED DURING THE OPERATION, THE SPRING COIL COULD NOT BE DEPLOYED. MECHANICAL DETACHMENT WAS TRIED MANY TIMES BUT WAS INEFFECTIVE. FINALLY, A VASCULAR CLAMP WAS USED TO ASSIST THE DETACHMENT. IT WAS REPLACED WITH NEW SPRING COIL TO COMPLETE THE SURGERY. THERE WAS INCREASED SURGICAL TIME AND RISKS. THE SPRING COIL DID NOT DEPLOY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303015 ↗

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