Class 2 Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system

• Date Initiated by Firm: March 19, 2007
• Date Posted: November 28, 2007
• Recall Status: Terminated 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: 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