BEUDAMED
    FDA Enforcement Class I Ongoing

    Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device

    Recall: Z-1921-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-1921-2024
    Event ID
    94478
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Thoratec Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2024
    Initiation Date
    May 8, 2024
    Classification Date
    June 7, 2024
    Address
    6035 Stoneridge Dr, N/A, Pleasanton, CA, 94588-3270, United States

    Description

    Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device

    Reason

    System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

    Code Info

    UDI-DI: 00813024010142, 00813024010852. All Serial Numbers

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GUADELOUPE, GREECE, IRELAND, ISRAEL, IRAN, ISLAMIC REPUBLIC OF, ITALY, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MARTINIQUE, NETHERLANDS, NORWAY, OMAN, POLAND, PALESTINE, PORTUGAL, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SWEDEN, SLOVENIA, TUNISIA, TURKEY, SOUTH AFRICA, CANADA, AUSTRALIA, HONG KONG, MALAYSIA, SINGAPORE, SOUTH KOREA, TAIWAN, THAILAND, JAPAN, BANGLADESH, INDIA, PAKISTAN, ARGENTINA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, MEXICO, and BRAZIL

    Quantity

    4,842