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U.S. Department of Health and Human Services

Class 2 Device Recall EndoPlege

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  Class 2 Device Recall EndoPlege see related information
Date Initiated by Firm December 03, 2010
Date Posting Updated January 28, 2011
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-0991-2011
Recall Event ID 57522
510(K)Number K964248  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary by pass - Product Code DWF
Product EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614.

The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters
Code Information Lot No.: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334.
Recalling Firm/
Edwards Lifesciences Llc
12050 Lone Peak Parkway
Draper UT 84020-9414
Manufacturer Reason
for Recall
Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
FDA Determined
Cause 2
Device Design
Action The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.
Quantity in Commerce 3,427 kits
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = HEARTPORT, INC.