GORE VIABIL Short Wire Biliary Endoprosthesis — Class II medical device recall Z-1179-2024
Ongoing recall by W.L. Gore & Associates, Inc., reported 2024-02-28, distributed nationwide. Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice
| Recall number | Z-1179-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W.L. Gore & Associates, Inc., Elkton, MD, United States |
| Recall initiated | 2024-01-19 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 24 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00733132638802, 00733132638871 |
| Serial numbers | 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428, 27063943, 27063944, 27063949, 27063950, 27063952, 27063953 |
| Model numbers | VSWVH1008, VSWVN1008 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1179-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.