BEUDAMED
    FDA Enforcement Class I Ongoing

    HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

    Recall: Z-1207-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1207-2022
    Event ID
    89966
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    April 14, 2022
    Classification Date
    June 3, 2022
    Address
    710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, 55432-5603, United States

    Description

    HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

    Reason

    The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.

    Code Info

    a) Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42312, HW42352, HW42775, HW42818, HW42879, HW42882, and HW42884. b) Model Number MCS1705PU: GTIN 00888707005364, Serial Numbers: HW42448 and HW42571; GTIN 00888707007139, Serial Numbers: HW42955 and HW42962; GTIN 00888707009041, Serial Numbers HW43483 and HW43484; and GTIN 00888707003070, Serial number HW42153.

    Distribution

    Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.

    Quantity

    21 pump implant kits