BEUDAMED
    FDA Recall Terminated

    Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

    Recall: Z-1152-2010 · Initiated March 19, 2009

    Recall

    Recall Number
    Z-1152-2010
    Event Number
    53477
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    NIM
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    March 19, 2009
    Posted
    March 16, 2010
    Terminated
    March 30, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

    Reason

    Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.

    Action

    Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.

    Distribution

    Nationwide: GA, NY, IN, LA, MA and PA

    Quantity

    49