# FDA recall Z-2914-2026

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2026-05-22.

## Product

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

## Reason for recall

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

## Distribution

U.S. Nationwide distribution in the states of GA and RI.

## Key facts

- **Recall number:** Z-2914-2026
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-22
- **Report date:** 2026-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Flagstaff, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2914-2026

## Citation

> AI Analytics. FDA recall Z-2914-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2914-2026. Source: US FDA. Licensed CC0.

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