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AxiumTM QC-22-50-3DRecalls & reported problems

Micro Therapeutics, Inc. · COIL QC-22-50-3D V04 AXIUM · Class 2 · Implant

All models of AxiumTM (139)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536030213), received between Aug 3, 2022 and Aug 3, 2022 — 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 16, 2026.

Most reported problems

Device problems

  • Material Deformation1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL THAT HAD RESISTANCE IN THE MICROCATHETER AND COULD NOT BE PUSHED OUT. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GRADE 3 ARTERIOVENOUS MALFORMATION. THE ABNORMALITY WAS NOT LOCATED IN THE ELOQUENT REGION. BLOOD FLOW WAS HIGH. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS NOTED WITH THE AXIUM COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER. THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. AFTER REMOVAL, IT WAS NOTED THE COIL WAS KINKED/DAMAGED. ON 2022-FEB-14 (B)(4) (FOR, HCP, REP): ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS STUCK IN THE MICROCATHETER AND COULD NOT BE PULLED OUT, AND THE MICROCATHETER WAS DAMAGED AT THE TIP END.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15156952 ↗

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

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Sources and updates

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