Recall Z-1593-2021 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
W.L. Gore & Associates, Inc.
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.
| Date | Apr 5, 2021 |
| Status | Terminated |
| Reason | The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. |
| Root cause | Process change control |
| Action | On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081184 | GORE VIABIL BILILARY ENDOPROSTHESIS W.L. Gore & Associates, Inc. Medical Products Div., Jul 22, 2008 |