BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.

    Recall: Z-2197-2012 · Initiated May 11, 2012

    Recall

    Recall Number
    Z-2197-2012
    Event Number
    62278
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 11, 2012
    Posted
    August 12, 2012
    Terminated
    June 17, 2014
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. 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.

    Action

    Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.

    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