# FDA recall Z-1179-2024

> **W.L. Gore & Associates, Inc.** · Class II · device recall initiated 2024-01-19.

## 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 for recall

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.

## Distribution

US Nationwide distribution in the state of Georgia.

## Key facts

- **Recall number:** Z-1179-2024
- **Recalling firm:** W.L. Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-19
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2024

## Citation

> AI Analytics. FDA recall Z-1179-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1179-2024. Source: US FDA. Licensed CC0.

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