Moderate riskFDA DeviceAug 19, 2026Class II

GORE VIABIL biliary endoprosthesis recalled over mislabeling

Some GORE VIABIL Short Wire Biliary Endoprosthesis devices labeled as model VSWVN1010 (10 mm by 10 cm, without transmural drainage holes) are actually model VSWVH1006 (10 mm by 7 cm, with transmural drainage holes). The recall covers 13 units, sold in Georgia and Rhode Island, and no injuries have been reported. The device is used to keep the common bile duct open when it is blocked.

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

What to do

Check the model number, UDI, and lot number on device packaging against the affected list.
Do not use affected units labeled VSWVN1010 with lot numbers 30965053 through 30965065.
Contact W L Gore & Associates for remedy and return instructions.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in: Nationwide
Made for: Adults (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-2914-2026

In the FDA's words

Description: 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. 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: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065. 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… (this page)
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…
Z-2915-2026 · 13 units