Class II — W.L. Gore & Associates, Inc.
| Recalling firm | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Gore post market surveillance team received a complaint that a GORE® VIABIL® Biliary Endoprosthesis appeared shorter than the labeled length. |
| 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. |
| Quantity | 61 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy. |
| Initiated | 2021-04-05 |
| Classified | 2021-05-14 |
| Terminated | 2024-01-16 |
| Recall number | Z-1593-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — W.L. Gore & Associates, Inc. (Z-1593-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87699/
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