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W.L. Gore & Associates, Inc. recalls GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH10
Recalled May 26, 2021 · FDA recall Z-1593-2021 · W.L. Gore & Associates
Hazard
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length. · FDA Class II
Units
61 devices
Sold at
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.
Description
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.
Manufacturer(s)
W.L. Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →