Biliary Endoprosthesis Recall: GORE VIABIL VSWVH0808/VSWVN1006
Announced 2026-10-21 · FDA
FDA recall involves the GORE VIABIL Short Wire Biliary Endoprosthesis models VSWVH0808 and VSWVN1006, with 32 units distributed in the United States (GA, RI). The issue is potential mislabeling of the devices' length, and no corrective action is specified.
| Brand | W L Gore & Associates, Inc. |
|---|---|
| Product | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. |
| Reason | The potential for the devices to be mislabeled with the incorrect length. |
| Severity | moderate |
| Units affected | 32 |
| Distribution | US Nationwide distribution in the states of GA, RI. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your healthcare provider to determine if you are affected.
- Do not modify or remove the device yourself; follow medical guidance.
- Visit FDA or Gore recall pages for updates and instructions.
How to identify the recalled item
| Lot / date codes | 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571; |
|---|---|
| Lot / date codes | 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571; |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other W L Gore & Associates, Inc. recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.