Axium Detachable Coil System QC-2.5-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037663), received between Jun 22, 2023 and Jun 22, 2023 — 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.

• MalfunctionJun 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED IN THE RIST CATHETER AND THE CATHETER WAS KINKED. THE COIL DETACHED IN THE CATHETER AND WAS TAKEN OUT FROM THE PATIENT AS A UNIT. SURGICAL INTERVENTION WAS NOT REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAM DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE RIST CATHETER WAS KINKED IN THE DISTAL LOCATION AT ARCH. CONTINUOUS FLUSH WAS ADMINISTERED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. VESSEL TORTUOUSITY WAS MODERATE. NO PATIENT SYMPTOSM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187779 ↗

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