W L Gore & Associates, Inc.: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary W L Gore & Associates is recalling certain GORE VIABIL Short Wire Biliary Endoprosthesis devices (models VSWVH0808 and VSWVN1006) used to keep bile ducts open because some devices may be mislabeled with incorrect length information. The recall affects devices distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, meaning there is potential for serious adverse health consequences but the devices are unlikely to cause permanent harm.
- Recalling firm
- W L Gore & Associates, Inc.
- 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.
- Reason
- The potential for the devices to be mislabeled with the incorrect length.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of GA, RI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3ba2a9dd-39d4-4811-bec9-615c1eb7c3d2