BEUDAMED
    FDA Recall Open, Classified

    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

    Recall: Z-1341-2021 · Initiated February 26, 2021

    Recall

    Recall Number
    Z-1341-2021
    Event Number
    87446
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 26, 2021
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

    Reason

    There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

    Action

    The firm issued a Medical Device Notice to its consignees on 02/26/2021 by letter delivered via UPS 2-day delivery. The letter explained the issue and directed the physician to review the patient management recommendations on the frequency of of inspecting the HVAD Controller, HVAD Controller power cables, and HVAD Monitor data cables. For questions regarding this material, please contact your Medtronic Field Representative.

    Distribution

    Worldwide

    Quantity

    3283 devices (1824 US)