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U.S. Department of Health and Human Services

Class 1 Device Recall Edwards Lifesciences EMBOLX Glide Protection System

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 Class 1 Recall
Edwards Lifesciences EMBOLX Glide Protection System
see related information
Date Posted October 31, 2013
Recall Status1 Open
Recall Number Z-0091-2014
Recall Event ID 66305
Premarket Notification
510(K) Numbers
K022071  K102420 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product 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.
Code Information Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper, Utah 84020-9414
For Additional Information Contact Suzanne Carpenter
801-565-6100
Manufacturer Reason
for Recall
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL-ACTION REQUIRED" letter dated September 16, 2013 via Fed-Ex to its consignees/customers. Consignees were asked to review inventory for the cannulae and remove the cannulae from any kits received; quarantine affected material at site and return product to Edwards LIfesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA #; call Edwards Customer Service at 800-424-3278 to obtain RGA# and replacement product (note: the filter is not affected and does not have to be returned with the cannulae); and complete and return the attached acknowledgment form via fax to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice. If you have any questions, please call Edwards Customer Service at 800-424-3278 from the hours 6:00am - 4:30pm PST or contact your Edwards' sales representative concerning the recall.
Quantity in Commerce 12,034
Distribution Worldwide distribution: US (nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.
510(K)s with Product Code = DWF and Original Applicant = EMBOL-X, INC.
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