BEUDAMED
    FDA Recall 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 abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

    Recall: Z-0873-2012 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-0873-2012
    Event Number
    55696
    Firm
    Micro Therapeutics Inc, dba ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    HCG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 1, 2010
    Posted
    January 26, 2012
    Terminated
    January 31, 2012
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    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 abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

    Reason

    ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.

    Action

    Micro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline. a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots. b) Based on the Health Hazard Assessment, the risk was considered undesirable. c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed. d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated. e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition. f) The ev3 Neurovascular Quality Assurance department scrapped the affected product. g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.

    Quantity

    13 units