Class II

Medical Device Recall: 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.

W L Gore & Associates, Inc. · May 22, 2026

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).

Distribution

U.S. Nationwide distribution in the states of GA and RI.

States Affected

NATIONWIDE

Quantity Affected

13 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2914-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

W L Gore & Associates, Inc. Medical Device Recall: 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. | SafeCheck