BEUDAMED
    FDA Recall Terminated

    Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.

    Recall: Z-1109-2007 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-1109-2007
    Event Number
    38342
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2007
    Posted
    July 27, 2007
    Terminated
    April 24, 2008
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.

    Reason

    Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths

    Action

    The firm has issued an Urgent Medical Device Correction notice dated March 30, 2007, to all VAD customers alerting them to the hazard. The letter instructs them that a Thoratec representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs them to dispose of any expired original design caged tip atrial cannula and to 1) not use the black collet and nut with any current design VAD, 2) make sure that all current patients using PVADs are using the appropriate collet nut, and 3) provide a copy of the product safety bulletin to all outlying hospitals and/or physicians that may be following patients implanted with PVADs and provide contact information with the acknowledgement form.

    Distribution

    Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.

    Quantity

    2,484 units