Class 2 Device Recall Bard Luminexx 3 Biliary Stent and Delivery System

• Date Initiated by Firm: July 21, 2005
• Date Posted: September 24, 2005
• Recall Status: Terminated on October 23, 2008
• Recall Number: Z-1585-05
• Recall Event ID: 32921
• 510(K)Number: K033497
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Bard Luminexx 3 Biliary Stent and Delivery System
• Code Information: Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St; Tempe AZ 85281-2438
• For Additional Information Contact: Shari L. Allen; 480-303-2720
• Manufacturer Reason for Recall: Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures.
• FDA Determined Cause: Other
• Action: Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.
• Quantity in Commerce: 102
• 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