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.

Class II

Recalling firm: W L Gore & Associates, Inc.
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).
Affected products (lot / model / serial): 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.
Units affected: 13 units
Distribution pattern: U.S. Nationwide distribution in the states of GA and RI.
Firm location: Flagstaff, AZ, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: E-Mail
Product type: Devices
Status: Ongoing
Recall number: Z-2915-2026
Recall initiated: May 22, 2026
FDA classification date: August 7, 2026
FDA report date: August 19, 2026
FDA event ID: 99143
Last updated on HTM Vibe: August 26, 2026