Class 2 Device Recall GORE VIABIL Short Wire Biliary Endoprosthesis

• Date Initiated by Firm: May 22, 2026
• Date Posted: August 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2914-2026
• Recall Event ID: 99143
• 510(K)Number: K170740
• Product Classification: Stents, drains and dilators for the biliary ducts - Product Code FGE
• Product: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
• Code Information: Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065.
• FEI Number: 2017233
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 1505 N 4th St; Flagstaff AZ 86004-5867
• For Additional Information Contact: Customer Care; 928-864-3600
• Manufacturer Reason for Recall: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
• FDA Determined Cause: Process control
• Action: On 05/22/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via email to customers informing them that, 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Customers are instructed to: . Identify and return any unused devices within the scope of this recall for replacement. . Complete and sign the enclosed CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com within 2 weeks of receipt of this notification. . 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 used device(s) on the CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com For questions or further assistance - contact Julie Skaife, Global Product Specialist & Brand Manager at juskaife@wlgore.com.
• Quantity in Commerce: 13 units
• Distribution: U.S. Nationwide distribution in the states of GA and 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