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

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

All models of Axium (28)

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 00836462010345), received between Jan 25, 2019 and Jan 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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

  • Separation Failure1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 25, 2019Separation Failure; Separation Failure

    MEDTRONIC RECEIVED REPORT THAT THE FIRST AXIUM COIL WAS PLACED, IT WAS FOUND THAT THE COIL CANNOT BE DETACHED BY INSTANT DETACHER. MANUALLY DETACH ALSO FAILED TO DETACH THE COIL. THE COIL FINALLY DETACHED BY USING TORQUE. AFTER THAT, ANOTHER 5 AXIUM PRIME COILS WERE PLACED AND DETACHED SUCCESSFULLY. NO PATIENT INJURY OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING THE DELIVERY. A CONTINUOUS FLUSH WAS USED. THE COIL WAS REPORTED TO HAVE BEEN REPOSITIONED 3 TIMES. THE DEVICES WERE ALL REPORTED TO HAVE BEEN PREPARED AND USED PER THE IFU. THE ANEURYSM IS IN THE RIGHT ICA BIFURCATION. IT IS SACCULAR AND RUPTURED. THE ANATOMY AND THE BLOOD FLOW WERE REPORTED TO BE NORMAL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8277789 ↗

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