BEUDAMED
    FDA Recall Open, Classified

    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

    Recall: Z-1313-2021 · Initiated March 3, 2021

    Recall

    Recall Number
    Z-1313-2021
    Event Number
    87490
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWA
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    March 3, 2021
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

    Reason

    An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

    Action

    In the United States (US), beginning 03-Mar-2021, a written Urgent Medical Device Correction letter was mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam

    Quantity

    387 devices (93 US)