BEUDAMED
    FDA Enforcement Class II Terminated

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    Recall: Z-1700-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1700-2015
    Event ID
    71169
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    May 5, 2015
    Classification Date
    June 2, 2015
    Termination Date
    October 17, 2016
    Address
    1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States

    Description

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    Reason

    The product failed to meet the internal established statistical test requirement for heparin activity.

    Code Info

    lot number 59860969.

    Distribution

    Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

    Quantity

    978