AxiumTM QC-8-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536029668), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.

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

• MalfunctionMay 1, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS FOUND TO BE KINKED AND ENCOUNTERED RESISTANCE UPON RETRIEVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED ANEURYSM IN THE CAROTID CAVERNOUS FISTULA WITH A MAX DIAMETER OF 12 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL WAS PARTIALLY DEPLOYED AT A CERTAIN LENGTH, THEN NOTED WITH ACUTE BEND WITHIN THE COIL. THE COIL WAS A TTEMPTED TO BE RETRIEVED HOWEVER IT GETS STUCK INSIDE THE MICROCATHETER TIP. HENCE, THE WHOLE SYSTEM INCLUDING THE MICROCATHETER AND PARTIALLY DEPLOYED COIL LENGTH WERE PULLED OUT. IT WAS REPORTED THERE WAS COIL KINK/DAMAGE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE WHOLE SYSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225060 ↗

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