[Recalled] 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 t
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | W.L. Gore & Associates, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1593-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 April 2021 |
| EAN / barcode | 22552467 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from W.L. Gore & Associates, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.