Axium Detachable Coil System QC-9-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037922), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 malfunction.

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

• MalfunctionMar 13, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER COULD NOT BE USED ANYMORE BECAUSE SOME PART OF THE BROKEN COIL WAS STUCK THE MICR OCATHETER. THE COIL WAS STUCK IN THE DISTAL SECTION OF THE CATHETER. COIL RESISTANCE/ STUCK IN MICROCATHETER. WHEN PULLED ON IT WAS BROKEN AND COULD NOT BE USED ANYMORE. HEALTHCARE PROVIDER (HCP) USED A BACKUP PRODUCT TO FINISH THE PROCEDURE. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF NEUROVASCULAR ABNORMALITIES, CAROTID-CAVERNOUS FISTULA (CCF).  IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597646 ↗

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