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Recall Observatory FDA recall evidence

Device 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.

Z-1593-2021

April 05, 2021

Class II

Product summary

Firm
W.L. Gore & Associates, Inc.
Event
Event 87699
Status
Terminated
Classification
Class II
Quantity
61 devices
Official record key
device-enforcement:Z-1593-2021

Official wording

Reason: The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.

Code information: Serial Number: 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, 22552763, 22552764, 22552765, 22552766, 22552767, 22552768, 22552769, 22552770, 22552771, 22552772, 22552773, 22552774, 22552775, 22552776, 22552777, 22552778, 22552779, 22552780, 22552781, 22552782, 22613929, 22613930, 22613931

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.