BEUDAMED
    FDA Recall Terminated

    Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Recall: Z-0015-2007 · Initiated January 26, 2004

    Recall

    Recall Number
    Z-0015-2007
    Event Number
    36138
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2004
    Posted
    October 4, 2006
    Terminated
    November 27, 2007
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588-3270

    Description

    Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Reason

    During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.

    Action

    On 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

    Distribution

    Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.

    Quantity

    11 units