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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system

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  Class 2 Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system see related information
Date Initiated by Firm March 19, 2007
Date Posted November 28, 2007
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-0179-2008
Recall Event ID 45436
510(K)Number K053404  
Product Classification Bilary stent system - Product Code FGE
Product Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614
Code Information Model EX080801CD; Lot FR6K0319
Recalling Firm/
Manufacturer		 Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Karen Kosnosky
949-250-2577
Manufacturer Reason
for Recall		 Failure to deploy.
FDA Determined
Cause 2		 Process control
Action This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.
Quantity in Commerce 12 units
Distribution Nationwide including states of OK, GA, CA WI, MO, and LA
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 = FGE and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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