BEUDAMED
    FDA Enforcement Class I Terminated

    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¿ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

    Recall: Z-0091-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0091-2014
    Event ID
    66305
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    September 16, 2013
    Classification Date
    October 31, 2013
    Termination Date
    March 10, 2017
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¿ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

    Reason

    Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

    Code Info

    Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.

    Distribution

    Worldwide distribution: US (nationwide) and country of: Canada.

    Quantity

    12,034