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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters

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  Class 2 Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters see related information
Date Initiated by Firm May 11, 2012
Date Posted August 12, 2012
Recall Status1 Terminated 3 on June 17, 2014
Recall Number Z-2190-2012
Recall Event ID 62278
510(K)Number K810352  
Product Classification Catheter, flow directed - Product Code DYG
Product Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J.

For use in patients who require hemodynamic monitoring.
Code Information 59174383, 59174384, 59216111, 59219855, 59233891, 59247471, 59252542
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-2500
Manufacturer Reason
for Recall		 The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
FDA Determined
Cause 2		 Process control
Action Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.
Quantity in Commerce 32,145 units for all products in Recall Event
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
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 = DYG and Original Applicant = AMERICAN EDWARDS LABORATORIES
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