AxiumTM NC-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032903), received between Nov 25, 2020 and Apr 28, 2021 — classified as 2 malfunctions.

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

• MalfunctionApr 28, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH AND ANOTHER THAT WAS STUCK AT THE CATHETER HUB. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR VESSEL TAKEDOWN. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE FIRST COIL FAILED TO DETACH WITH THE INSTANT DETACHER. ONLY ONE INSTANT DETACHER WAS USED AND MANUAL DETACHMENT WAS NOT ATTEMPTED. THE SECOND COIL HAD RESISTANCE IN THE SHEATH AND COULD NOT ENTER THE ECHELON MICROCATHETER HUB. THE COILS WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738630 ↗
• MalfunctionNov 25, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE LOT # OF THE INSTANT DETACHER USED WAS UNAVAILABLE. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK DURING HYDRATION. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905859 ↗

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