Class 3 Device Recall Sentinol Nitinol Biliary Stent System

• Date Initiated by Firm: May 14, 2004
• Date Posted: January 25, 2006
• Recall Status: Terminated on January 23, 2007
• Recall Number: Z-0440-06
• Recall Event ID: 32924
• 510(K)Number: K032025
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall.
• Code Information: UPN # H7493894886070, lot # 6412353
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; 1 Scimed Pl; Maple Grove MN 55311-1565
• Manufacturer Reason for Recall: One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.
• FDA Determined Cause: Other
• Action: A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product.
• Quantity in Commerce: 20
• Distribution: Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates
• 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