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U.S. Department of Health and Human Services

Class 2 Device Recall Endopledge Sinus Catheter Kit

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 Class 2 Recall
Endopledge Sinus Catheter Kit
see related information
Date Posted July 11, 2011
Recall Status1 Terminated on June 01, 2012
Recall Number Z-2776-2011
Recall Event ID 59135
Premarket Notification
510(K) Numbers
K964248  K981909 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. Device 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 catheter contamination guard, is packaged with these catheters.
Code Information Lot numbers: 751029B, 751036B, 751041B, 755814AB, 763115B, 763119B, 763123B, 763125B, 763127B, 763128B, 763129B, 774333B, 774334B, 774336B, 774337, 774337B, 784527B, 794302B, 794303, 794586, 798587, 818578, 818581, 821595, 831328, 833441, 841434, 848624, 848628, 848632, 856438, 856502, 856509, 856510, 856513,
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper, Utah 84020-9414
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at: Edwards Lifesciences 12060 Lone Peak Pkwy Draper, UT 84020 Attention: Suzanne Carpenter, RGA # Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.
Quantity in Commerce 2798 units
Distribution Nationwide Distribution.
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 = BAXTER EDWARDS
510(K)s with Product Code = DWF and Original Applicant = HEARTPORT, INC.
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