AxiumTM QC-6-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536030015), received between Feb 21, 2022 and Feb 21, 2022 — 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.

• MalfunctionFeb 21, 2022Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AN AXIUM COIL GETTING STUCK. THE AXIUM COIL WAS BEING INTRODUCED THROUGH THE MICROCATHETER, AND AFTER INTRODUCING A BALLOON UPON THE NECK OF THE ANEURYSM, THE COIL WAS STUCK INSIDE THE ANEURYSM AND THE MICROCATHETER. WHEN TRYING TO RETRIEVE THE COIL IT WAS DETACHED WHILE TRYING TO PULL THE SYSTEM. THE COIL WAS STUCK IN THE MIDDLE SECTION OF THE CATHETER. THE CATHETER WAS NOT DAMAGED, HOWEVER, THE COIL WAS DAMAGED AT THE IMPLANT COIL SITE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: AN EXCELSIOR SL-10 MICROCATHETER. IT WAS REPORTED THAT ENTER EVENT DETAILS HERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13572772 ↗

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