Class 2 Device Recall GORE VIABIL Biliary Endoprosthesis

• Date Initiated by Firm: September 03, 2026
• Date Posted: October 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0158-2027
• Recall Event ID: 99873
• 510(K)Number: K170740
• Product Classification: Stents, drains and dilators for the biliary ducts - Product Code FGE
• Product: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: 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.
• Code Information: 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571
• FEI Number: 2017233
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 1505 N 4th St; Flagstaff AZ 86004-5867
• For Additional Information Contact: 800-5288763
• Manufacturer Reason for Recall: The potential for the devices to be mislabeled with the incorrect length.
• FDA Determined Cause: Under Investigation by firm
• Action: On September 8, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: Identify and return any unused devices within the scope of this recall for replacement. Please acknowledge receipt of this letter according to the instructions provided by our distributor, Olympus. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). 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. If a listed device has been used, please indicate the device(s) used when you acknowledge receipt according to the enclosed instruction from our distributor, Olympus
• Quantity in Commerce: 32
• Distribution: US Nationwide distribution in the states of GA, RI.
• 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