BEUDAMED
    FDA Recall Terminated

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    Recall: Z-0620-2013 · Initiated December 5, 2012

    Recall

    Recall Number
    Z-0620-2013
    Event Number
    63915
    Firm
    SynCardia Systems Inc.
    FEI Number
    3003761017
    Product Code
    DSZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 5, 2012
    Posted
    December 28, 2012
    Terminated
    June 7, 2013
    Address
    1992 E Silverlake Rd, Tucson, AZ, 85713-3865

    Description

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    Reason

    Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.

    Action

    Syncardia Systems sent a" Urgent Field Safety Notice" dated December 10, 2012, to all affected customers. The letter identified the product the problem and what action the customer needs to take.. The letter informed the customers that there were 3 reported thermal battery events (2 of which occurred on-site at either SynCardia or at the battery manufacturer, Dow Kokam, and one incident that occurred in the field) which caused physical damage to the batteries including burning and/or charring. The batteries were not in use with a patient at time of the reported issue, and there were no reports of any adverse impact to any patient or user. Customers are instructed to follow the directions on the attached Return page, and return their customer response form to SynCardia as soon as possible. Customers with questions are instructed to call (520) 545-1234 or (520) 440-7593.

    Distribution

    Worldwide Distribution -- US (nationwide)

    Quantity

    81 units