GORE VIBIL Biliary Endoprosthesis: stents — Class II medical device recall Z-1593-2021
Terminated recall by W.L. Gore & Associates, Inc., reported 2021-05-26, distributed nationwide. The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appear
| Recall number | Z-1593-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W.L. Gore & Associates, Inc., Elkton, MD, United States |
| Recall initiated | 2021-04-05 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2024-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, PT |
| Quantity | 61 devices |
| Reason classes | labeling |
| Serial numbers | 22552467, 22552468, 22552469, 22552470, 22552471, 22552472, 22552473, 22552474, 22552475, 22552476, 22552477, 22552478, 22552479, 22552480, 22552481, 22552482, 22552483, 22552484, 22552756, 22552757, 22552758, 22552759, 22552760, 22552761, 22552762 and 23 more |
| Model numbers | VH1008040, VH1010040, VN0808200, VN1010040 |
Product
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
Reason for recall
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
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-1593-2021. 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.