BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

    Recall: Z-2189-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2189-2012
    Event ID
    62278
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    May 11, 2012
    Classification Date
    August 12, 2012
    Termination Date
    June 17, 2014
    Address
    1 Edwards Way, Irvine, CA, 92614-5688, United States

    Description

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

    Reason

    The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.

    Code Info

    59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

    Quantity

    32,145 units for all products in Recall Event