Axium Detachable Coil System QC-22-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536038028), received between Jun 23, 2025 and Jun 23, 2025 — 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 23, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS PREMATURELY DETACHED, THE BALLOON-ASSISTED MICROCATHETER EXHIBITED A LEAK, AND THE GUIDEWIRE ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING TREATMENT FOR NEUROVASCULAR ABNORMALITY, CAROTID CAVERNOUS ARTERIOVENOUS FISTULA; IT WAS UNKNOWN WHETHER THE ABNORMALITY WAS LOCATED IN THE ELOQUENT REGION. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT A BALLOON-ASSISTED MICROCATHETER WAS SELECTED, AND THE 6F INTERMEDIATE TUBE WAS USED AS SUPPORT. THE BALLOON WAS HYDRATED IN VITRO AND THEN DEFLATED AND PRE-FILLED. WHEN THE X-PEDION-10 GUIDEWIRE WAS OUT OF THE DISTAL END OF THE BALLOON, IT WAS FOUND TO BE STUCK. THE GUIDEWIRE WAS ABOUT 3CM OUT OF THE BALLOON CATHETER TIP END. WHEN THE BALLOON WAS FILLED WITH A CARD-TYPE SYRINGE, IT WAS FOUND THAT THE BALLOON TIP END WAS LEAKING, AND THE BALLOON COULD NOT BE FILLED. THE MICROCATHETER REACHED THE ARTERIAL FISTULA AND DEPLOYED THE DETACHABLE SPRING COIL THROUGH IT. IT WAS ACCIDENTALLY DETACHED IN THE MICROCATHETER. THE SURGEON SAID THAT THERE WAS A QUALITY PROBLEM WITH THIS STENT AND ASKED TO REPLACE IT WITH A DETACHABLE SPRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309342 ↗

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