FDA recall Z-1593-2021

W.L. Gore & Associates, Inc. · Class II · 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.

Reason for recall

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

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.

Key facts

Status
Terminated
Initiation date
2021-04-05
Report date
2021-05-26
Termination date
2024-01-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2021