Moderate riskFDA DeviceAug 19, 2026Class II

GORE VIABIL biliary stent recalled for incorrect product labeling

W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprosthesis devices. Some units with catalogue number VSWVH1006 (10 mm by 7 cm, with transmural drainage holes) were labeled as VSWVN1010 (10 mm by 10 cm, without drainage holes). The recall covers lot numbers 30970948 through 30970960, distributed in Georgia and Rhode Island. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Gore recalls

What to do

Check the catalogue number and UDI (00733132638796) on any GORE VIABIL stent in inventory.
If the product is VSWVH1006 but labeled as VSWVN1010, stop using it and set it aside.
Contact W L Gore & Associates for instructions on returning or handling the affected devices.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 13 units
Illnesses reported: None reported
Manufactured in: 1505 N 4th St, Flagstaff, AZ, United States
Classification: Class II
Recall number: Z-2915-2026

In the FDA's words

Description: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. 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). Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960. Distribution: U.S. Nationwide distribution in the states of GA and RI. Affected quantity: 13 units
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).

2 products in this recall

The agency lists each product separately. Check every one you might have.

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the commo…
Z-2914-2026 · 13 units
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the commo… (this page)
Z-2915-2026 · 13 units