BEUDAMED
    FDA Enforcement Class I Ongoing

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    Recall: Z-1832-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1832-2017
    Event ID
    76807
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2017
    Initiation Date
    March 10, 2017
    Classification Date
    April 24, 2017
    Address
    14400 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    Reason

    In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.

    Code Info

    Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015

    Distribution

    Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.

    Quantity

    9 units