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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product 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 to0ยค 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Recall Number Z-0091-2014
Classification Class I
Code Info Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Product Distributed Qty 12,034
Reason For Recall Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

Event Detail

Event Id 66305
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) and country of: Canada.
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