Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GORE VIBIL Biliary Endoprosthesis: stents Recalled by W.L. Gore & Associates, Inc. Due to The Gore post market surveillance team received a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact W.L. Gore & Associates, Inc. directly.
Affected Products
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
Why Was This Recalled?
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About W.L. Gore & Associates, Inc.
W.L. Gore & Associates, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report