Axium Detachable Coil System QC-12-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037526), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 injury.

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.

• InjuryOct 30, 2025Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY OF THE COIL, THE OPERATOR FOUND THAT THE COIL BODY HAD DETACHED FROM THE PUSHER ROD. AT THIS POINT, THE COIL COULD NOT BE RETRIEVED AND COULD ONLY BE PUSHED FURTHER; HOWEVER, THE COIL COULD NO LONGER BE PRECISELY DELIVERED INTO THE ANEURYSM THROUGH THE PUSHER ROD, RESULTING IN PART OF THE COIL REMAINING FREE WITHIN THE PATIENT¿S VESSEL. TO ENSURE PATIENT SAFETY, THE OPERATOR DEPLOYED AN ADDITIONAL STENT TO PRESS THE FREE COIL AGAINST THE VESSEL WALL. THE IMPLANT COIL REMAINS IN THE PATIENT. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 1 TIME. 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 REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SAC

  Patient problems: Foreign Body In Patient

  MAUDE report 23425629 ↗

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