FDA recall Z-2914-2026

W L Gore & Associates, Inc. · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2026-05-22
Report date
2026-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Flagstaff, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2914-2026