BEUDAMED
    FDA Recall Terminated

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    Recall: Z-2731-2015 · Initiated August 6, 2015

    Recall

    Recall Number
    Z-2731-2015
    Event Number
    71905
    Firm
    SynCardia Systems Inc.
    FEI Number
    3003761017
    Product Code
    LOZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 6, 2015
    Posted
    September 17, 2015
    Terminated
    November 4, 2015
    Address
    1992 E Silverlake Rd, Tucson, AZ, 85713-3865

    Description

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    Reason

    SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.

    Action

    SynCardia sent an Urgent Medical Device Recall letter dated August 6, 2015 to affected customers. The letter identified the purpose, reason for the voluntary recall, risk to health, how to recognize that the device may fail, actioms to be taken by the customer/user, product and distribution information and type of action by the company. Customer were instructed to completed and return Recall Acknowledgement and Receipt Form to SynCardia. A SynCardia Clinical Support Specialist or other SynCardia representative will assist customers with replacement product and returning affected product. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, Inc 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time Hotline 24/7 866-771-9437 www.syncardia.com

    Distribution

    Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.

    Quantity

    56 drivers (21 currently in use on patients)