BEUDAMED
    FDA Enforcement Class II Ongoing

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Recall: Z-1022-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1022-2023
    Event ID
    91330
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SynCardia Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    November 2, 2022
    Classification Date
    January 27, 2023
    Address
    1992 E Silverlake Rd, N/A, Tucson, AZ, 85713-3865, United States

    Description

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Reason

    Due to tears reported tears in the cannula due to wear and tear stress.

    Code Info

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    1,732 systems