BEUDAMED
    FDA Recall Terminated

    CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure

    Recall: Z-0645-2009 · Initiated November 26, 2008

    Recall

    Recall Number
    Z-0645-2009
    Event Number
    50502
    Firm
    Edwards Lifesciences Research Medical, Inc.
    FEI Number
    1713910
    Product Code
    DXC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 26, 2008
    Posted
    January 5, 2009
    Terminated
    August 10, 2011
    Address
    6864 South 300, West Midvale, UT, 84047

    Description

    CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure

    Reason

    Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

    Action

    All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278.

    Distribution

    Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.

    Quantity

    963 units