Class II — W.L. Gore & Associates, Inc.
| Recalling firm | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. 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. |
| Product | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes |
| Quantity | 24 |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Initiated | 2024-01-19 |
| Classified | 2024-02-22 |
| Recall number | Z-1179-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — W.L. Gore & Associates, Inc. (Z-1179-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93882/
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