AxiumTM QC-8-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536030084), received between Mar 23, 2020 and Oct 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS POTENTIALLY DAMAGE TO THE AXIUM COIL. THE PHYSICIAN SEEMED TO THINK THERE WAS A PART OF THE AXIUM COIL LEFT IN THE COILING CATHETER WHICH CAUSED THE FOLLOWING HYDROGEL COIL TO GET STUCK. CATHETER NEEDS TO BE INSPECTED TO CONFIRM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007301 ↗
• MalfunctionJul 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PROCEDURE WAS COMPLETED BY USING OTHER AXIUM COILS AFTER RETRIEVING THE DETACHED COIL FROM THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243522 ↗
• MalfunctionMar 23, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL SEPARATED IN THE CATHETER DURING DELIVERY. THE CATHETER WITH THE COIL WAS REMOVED FROM THE PATIENT, AND REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A FUBUKI GUIDE CATHETER, AND HEADWAY 17 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865395 ↗

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