W.L. Gore & Associates, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1179-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes

Product Classification:

Class II

Date Initiated: January 19, 2024

Date Posted: February 28, 2024

Recall Number: Z-1179-2024

Event ID: 93882

Reason for Recall:

Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. 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.

Status: Ongoing

Product Quantity: 24

Code Information:

(1) UDI-DI 00733132638802, Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953; (2) UDI-DI 00733132638871, Serial Numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428

Distribution Pattern:

US Nationwide distribution in the state of Georgia.

Voluntary or Mandated:

Voluntary: Firm initiated