AxiumTM QC-3-4-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536029873), received between Jun 1, 2020 and May 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionMay 4, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A PROCEDURE, THE AXIUM COIL WAS STUCK AT THE DISTAL PART OF THE MICROCATHETER. THE COIL WAS STRETCHED AND DETACHED AT THE ANTERIOR CEREBELLAR ARTERY (ACA) AND WAS DIFFICULT TO BE TAKEN OUT. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE CATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ACA ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 2.8MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279486 ↗
• MalfunctionJun 1, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND WAS FOUND TO BE BROKEN IN THE MIDDLE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 3MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHEN THE AXIUM COIL WAS DEPLOYED TO 3/5 WITH NO RESISTANCE, IT WAS AUTOMATICALLY DETACHED. THE SURGEON WITHDREW THE COIL AND MICROCATHETER TOGETHER. IT WAS FOUND THE MIDDLE OF THE COIL WAS BROKEN, AND THE PUSHWIRE WAS DAMAGED. THE MICROCATHETER WAS THEN RE-USED WITH A NEW COIL TO COMPLETE THE EMBOLIZATION PROCEDURE WITH NO ISSUES. DURING THE PROCEDURE, A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, NO ATTEMPTS TO DETACH THE COIL WERE MADE, AND THE PHYSICIAN HAD REPOSITIONED THE COIL ONE TIME. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10107129 ↗

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