BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

    Recall: Z-2777-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2777-2015
    Event ID
    72136
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    September 1, 2015
    Classification Date
    September 16, 2015
    Termination Date
    April 8, 2016
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391, United States

    Description

    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

    Reason

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    Code Info

    serial numbers: 5K0005, 5K0006, 5K0007, 5K0009, 5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030, 5K0031, 5K0032, 5K0033, 5K0034, 5K0035, 5K0036, 5K0037, 5K0039, 5K0040, 5K0041, 5K0042, 5K0043, 5K0044, 5K0045, 5K0046, 5K0047, 5K0048, 5K0053, 5K0054, 5K0056, 5K0057, 5K0058, 5K0059, 5K0062, 5K0063, 5K0064, 5K0065, 5K0066, 5K0067, 5K0068, 5K0069, 5K0070, 5K0071, 5K0072, 5K0073, N5923, N5924, N5925, N5929, N5930, N5931, N5932, N5933, N6106, N6119, N6210, N6720, N7763, N7764, N7765, N7766, N7767, N7768, N7769, N7770, N7771, N7772, N7773, N7774, N7775, N7776, N7777, N7778, N7779, N7780, N7781, N7782, N7783, N7784, N7785, N7786, N7787, N8029, N8030, N8031, N8033, N8034, N8035, N8038, N8039, N8040, N8041, N8042, N8043, N8044, N8045, N8046, N8047, N8048, N8049, N8050, N8051, N8052, N8053, N8054, N8055, N8056, N8057, N8058, N8059, N8060, N8061, N8062, N8063, N8064, N8065, N8067, N8068, N8069, N8070, N8072, N8073, N8074.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    103 units