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U.S. Department of Health and Human Services

Class 2 Device Recall Coronary sinus catheter

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 Class 2 Recall
Coronary sinus catheter
see related information
Date Posted January 28, 2011
Recall Status1 Terminated on October 27, 2011
Recall Number Z-0992-2011
Recall Event ID 57522
Premarket Notification
510(K) Number
K023880 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The Steerable 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 Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
Code Information Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
Recalling Firm/
Manufacturer
Edwards Lifesciences Llc
12050 Lone Peak Parkway
Draper, Utah 84020-9414
Consumer Instructions No consumer action necessary
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
DESIGN: Component Design/Selection
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 90 kits
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 = ETHICON, INC.
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