W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis

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).

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2915-2026
• FDA 510(k) clearance · K170740The device's official FDA premarket clearance record
• FDA device classification · FGEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find W L Gore & Associates, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.