BEUDAMED
    FDA Recall Terminated

    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

    Recall: Z-0306-05 · Initiated November 19, 2004

    Recall

    Recall Number
    Z-0306-05
    Event Number
    30623
    Firm
    Edwards Lifesciences Research Medical Inc
    FEI Number
    1713910
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2004
    Posted
    December 15, 2004
    Terminated
    January 7, 2005
    Address
    6864 South 300, West Midvale, UT, 84047-1083

    Description

    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

    Reason

    Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

    Action

    All consignees were notified by letter on 11/22/2004

    Distribution

    AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.

    Quantity

    396 units