AxiumTM APB-6-12-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536008267), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionDec 13, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 AXIUM PRIME COILS AND 1 CONCERTO COIL FAILED TO DETACH. IT WAS REPORTED THAT UPON DELIVERY OF THE COIL, DETACHMENT WAS ATTEMPTED USING THE INSTANT DETACHER (ID), BUT THE COIL DID NOT DETACH. THEN DETACHMENT WAS ATTEMPTED WITH THE HYPOTUBE BREAK METHOD, BUT THE COIL DID NOT DETACH. 2 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND ONE ATTEMPT WAS MADE VIA THE SECOND DETACHMENT METHOD. THE PUSHWIRE WAS SEATED DEEP INTO THE ID WHEN THE DETACHMENT ATTEMPTS WERE MADE. THE DEVICES WERE RETRIEVED AND REMOVED FROM THE ANATOMY. THE COILS WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED, AND COILS WERE HYDRATED PER THE IFU. CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE ID AND THE COILS WILL BE RETURNED FOR ANALYSIS. NO ISSUES WERE REPORTED WITH THE ID. THE ANATOMY WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161126 ↗

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