W.L. Gore & Associates, Inc. Recall 87699
Description: 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.
W.L. Gore & Associates, Inc. Recall 87699 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1593-2021 |
| Event ID | 87699 |
| Event Description | 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. |
| Product Type | 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. |
| Quantity | 61 devices |
| Recall Reason | The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length. |
| Device Classification | 20210526 |
| Device Code Info | 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 |
| Center Classification Date | 20210514 |
| Recall Initiation Date | 20210405 |
| Recalling Firm | W.L. Gore & Associates, Inc. |
| Initial Notification | Letter |
| Similar To |