Class 2 Device Recall LifeStent FlexStar Stent System

• Date Initiated by Firm: August 29, 2008
• Date Posted: October 10, 2008
• Recall Status: Terminated on April 06, 2012
• Recall Number: Z-0078-2009
• Recall Event ID: 49405
• 510(K)Number: K053404
• Product Classification: Catheter - Product Code FGE
• Product: Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
• Code Information: Lot Numbers: FR6K0277A, FR6K0307, FR6K0323, R58279724, R58285864, R58308046, and R58316537
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St; Tempe AZ 85281-2438
• For Additional Information Contact: 480-894-9515
• Manufacturer Reason for Recall: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
• FDA Determined Cause: Process control
• Action: The customer letters for the tip to sheath gap were sent on 8/29/2008 with return receipt. The letter advises that C.R. Bard has determined that some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. Per the letter, the firm's analysis has determined that a gap between the tip of the delivery system and the delivery system sheath may be associated with difficult advancement to the treatment site. Users are instructed to inspect all devices to verify that there is not a gap between the tip and sheath (orange colored guidewire lumen is visible), prior to use and to not use any devices that exhibit a tip to sheath gap condition. If devices that exhibit a tip to sheath gap are identified, customers are advised to call Customer Service at 1-800-321-4254 to return the device and a replacement will be provided at no cost. The letter also advises that the Instructions for Use for the LifeStent FlexStar System will be updated to include the inspection step which is provided in the letter.
• Quantity in Commerce: 259 units
• Distribution: Nationwide
• 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