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-1604-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1604-2015
    Event ID
    71099
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HeartWare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 20, 2015
    Initiation Date
    April 29, 2015
    Classification Date
    May 14, 2015
    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

    Failures of the splice repair kit if exposed to excessive force.

    Code Info

    Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816

    Distribution

    Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.

    Quantity

    35