GORE VIABIL Biliary Endoprosthesis Recall
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal pat
Updated May 22, 2026
Some GORE VIABIL Short Wire Biliary Endoprosthesis devices were labeled with incorrect specifications. Devices marked as 10 mm diameter x 10 cm without drainage holes may actually be 10 mm diameter x 7 cm with drainage holes, which could affect their function in treating bile duct obstruction.
Is the W L Gore & Associates, Inc. recalled? Yes. This product was recalled by FDA on May 22, 2026. Details below.
What is recalled
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010 (10 mm diameter x 10 cm length without transmural drainage holes), manufactured by W L Gore & Associates, Inc. Some units may be mislabeled and actually contain Model No. VSWVH1006 specifications (10 mm diameter x 7 cm with transmural drainage holes).
Am I affected
You are affected if you are a healthcare provider or facility that received or implanted GORE VIABIL Model No. VSWVN1010 devices. Check the device packaging label for the model number and specifications before use or implantation.
What to do right now
Stop using any GORE VIABIL Model No. VSWVN1010 devices and contact W L Gore & Associates, Inc. immediately to verify the correct specifications of your inventory. Do not implant these devices until the labeling has been confirmed as accurate.
The hazard
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).
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2914-2026
- Classification
- Class II
- Recalled
- May 22, 2026
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