BEUDAMED
    FDA Recall Terminated

    Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951

    Recall: Z-1211-2007 · Initiated July 16, 2007

    Recall

    Recall Number
    Z-1211-2007
    Event Number
    39147
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2007
    Posted
    August 29, 2007
    Terminated
    June 14, 2011
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951

    Reason

    The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.

    Action

    The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.

    Distribution

    Nationwide

    Quantity

    43 units