FDA Device recall Z-0158-2027
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis by W L Gore And Associates, citing the potential for the devices to be mislabeled with the incorrect length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0158-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-03 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
Product
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: 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.
Reason
The potential for the devices to be mislabeled with the incorrect length.
Identifiers
| code_info | 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036,…1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by W L Gore And Associates
- GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada…
FDA Device · Class II · 2026-07-08 · W L Gore And Associates - GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040…
FDA Device · Class II · 2025-10-08 · W L Gore And Associates - Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, B…
FDA Device · Class II · 2024-09-11 · W L Gore And Associates
All W L Gore And Associates recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0158-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.