BEUDAMED
    FDA Recall Terminated

    Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108

    Recall: Z-0491-03 · Initiated December 16, 2002

    Recall

    Recall Number
    Z-0491-03
    Event Number
    25262
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2002
    Posted
    January 30, 2003
    Terminated
    August 21, 2003
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108

    Reason

    The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.

    Action

    On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

    Distribution

    The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.

    Quantity

    45 units