BEUDAMED
    FDA Recall Terminated

    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

    Recall: Z-0698-2017 · Initiated November 9, 2016

    Recall

    Recall Number
    Z-0698-2017
    Event Number
    75632
    Firm
    Elana, Inc.
    FEI Number
    3006784599
    Product Code
    PAX
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    November 9, 2016
    Terminated
    December 20, 2016
    Address
    10480 Little Patuxent Pkwy, Ste 400, Columbia, MD, 21044-3576

    Description

    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

    Reason

    Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.

    Action

    Elana sent an Urgent Medical Device Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected device and to return the product for replacement. Customers were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return and exchange. Customers with questions were instructed to call 301-215-7010.

    Distribution

    Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.

    Quantity

    4