Skip to content

AxiumTM QC-4-8-3DRecalls & reported problems

Micro Therapeutics, Inc. · COIL QC-4-8-3D V04 AXIUM · Class 2 · Implant

All models of AxiumTM (139)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536029958), received between Jan 27, 2021 and Dec 2, 2021 — classified as 2 malfunctions.

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

Device problems

  • Material Deformation2
  • Detachment of Device or Device Component1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionDec 2, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT AFTER FLUSHING THE COIL PER USUAL, THE DETACHMENT POINT OF THE AXIUM COIL WAS FOUND TO BE DAMAGED. THE COIL WAS PUSHED OUT OF THE PROTECTIVE SHEATH AND IT WAS FOUND THAT THE COIL WAS DETACHED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR LEFT OPHTHALMIC ARTERY SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW WAS LOW, VESSEL TORTUOSITY WAS MODERATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12917363 ↗
  • MalfunctionJan 27, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11234880 ↗

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

Other Device, Vascular, for Promoting Embolization devices

All Device, Vascular, for Promoting Embolization devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page