FDA Device recall Z-1179-2024
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm by W L Gore And Associates, citing devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1179-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-19 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
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
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.
Identifiers
| code_info | (1) UDI-DI 00733132638802, Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953; (2) UDI-DI 007331…(1) UDI-DI 00733132638802, Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953; (2) UDI-DI 00733132638871, Serial Numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2024%22
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