AxiumTM QC-10-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536030138), received between Apr 1, 2025 and Apr 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 27, 2022Open, Classified

   Due to incorrect size and configuration labeling of the detachable coil system.

   Z-1261-2022 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS PUSHED OUT AND THE DIAMETER OF THE COIL WAS FOUND TO BE LESS THAN 10MM. THE COIL WAS REMOVED AND IT WAS FOUND THAT IT WAS A 2D COIL PACKAGED AS A 3D COIL. A NEW COIL WAS PLACED AND THE ISSUE WAS RESOLVED. 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, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 10MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767143 ↗
• MalfunctionApr 1, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STRETCHED DURING THE DELIVERY IN THE MICROCATHETER AND COULD NOT BE PUSHED OUT SMOOTHLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT C6 WITH A MAX DIAMETER OF 12.6MM AND A 5.48MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS STRETCHED DURING DELIVERY IN THE MICROCATHETER AND COULD NOT BE PUSHED OUT SMOOTHLY. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO OTHER OTHER ISSUES DURING THAT PROCEDURE THAT WOULD HAVE CAUSED THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746183 ↗

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