Axium QC-5-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010154), received between Dec 20, 2019 and Dec 20, 2019 — 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.

• MalfunctionDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COIL PREMATURELY DETACHED. PRIOR TO THE EVENT, AN ECHELON MICROCATHETER WAS PLACED IN THE ANEURYSM AND ONE AXIUM COIL WAS SUCCESSFULLY IMPLANTED IN THE ANEURYSM. THEN THE PHYSICIAN INTRODUCED THE AXIUM QC 3D (REPORTED DEVICE) AND INTRODUCED IT HALFWAY AND THE COIL CAME OUT INTO THE PARENT ARTERY. THE PHYSICIAN PULLED THE COIL BACK TO REPOSITION IT, BUT RESISTANCE WAS FELT AND IT PREMATURELY DETACHED. HALF OF THE COIL WAS HANGING IN THE PARENT ARTERY AND IT WAS REMOVED WITH THE HELP OF THE REBAR 27 AND SOLITAIRE 2 (6 X 30). NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A RUPTURED ANEURYSM MEASURING 7MM X 3.78MM LOCATED IN THE A-COMM. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VASCULATURE WAS MODERATE IN TORTUOSITY. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN ONLY ATTEMPTED TO REPOSITION THE COIL ONCE. THERE WAS NO ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER. A CONTINUOUS FLUSH WAS ADMINISTERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9506963 ↗

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