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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 Catheterssee related information
Date Initiated by FirmMay 11, 2012
Date PostedAugust 12, 2012
Recall Status1 Terminated 3 on June 17, 2014
Recall NumberZ-2198-2012
Recall Event ID 62278
510(K)NumberK810352 
Product Classification Catheter, flow directed - Product Code DYG
ProductEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Code Information 59267057
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
ActionEdwards 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 Commerce32,145 units for all products in Recall Event
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DYG
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