Class 2 Device Recall GORE VIABIL Short Wire Biliary Endoprosthesis

• Date Initiated by Firm: January 19, 2024
• Date Posted: February 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1179-2024
• Recall Event ID: 93882
• 510(K)Number: K170740
• Product Classification: Stents, drains and dilators for the biliary ducts - Product Code FGE
• Product: GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as; (1) Catalog Number VSWVH1008, 10 mm x 8 cm;; with holes; and; (2) Catalog Number VSWVN1008, 10 mm x 8 cm;; no holes
• Code Information: (1) UDI-DI 00733132638802, Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953; (2) UDI-DI 00733132638871, Serial Numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428
• Recalling Firm/ Manufacturer: W.L. Gore & Associates, Inc.; 301 Airport Rd; Elkton MD 21921-4130
• For Additional Information Contact: 800-528-8763
• Manufacturer Reason for Recall: Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
• FDA Determined Cause: Packaging process control
• Action: On January 19, 2024, the firm notified their distributor via emailed notification. The distributor was instructed to distribute the recall notification to affected end customers. The recall notification, titled URGENT MEDICAL DEVICE RECALL, instructs customers to inspect their inventory for the affected serial numbers and to remove and return any affected product. Accounts with ConMed Corporation consignment inventory should allow their ConMed territory manager to arrange the retrieval of potentially affected consignment inventory. If product has been further distributed, please notify all downstream accounts. Implanting Physicians: If you have implanted one of the potentially mislabeled GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis devices, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazards associated with this mislabeling.
• Quantity in Commerce: 24
• Distribution: US Nationwide distribution in the state of Georgia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FGE and Original Applicant = W.L. Gore & Associates, Inc.