BEUDAMED
    FDA Recall Open, Classified

    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

    Recall: Z-2059-2020 · Initiated April 3, 2020

    Recall

    Recall Number
    Z-2059-2020
    Event Number
    85397
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 3, 2020
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

    Reason

    The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

    Action

    The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A.

    Distribution

    Worldwide Distribution

    Quantity

    560 units