# FDA recall Z-1593-2021

> **W.L. Gore & Associates, Inc.** · Class II · device recall initiated 2021-04-05.

## Product

GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.

## Reason for recall

The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of  AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.

## Key facts

- **Recall number:** Z-1593-2021
- **Recalling firm:** W.L. Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-05
- **Report date:** 2021-05-26
- **Termination date:** 2024-01-16

- **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-1593-2021

## Citation

> AI Analytics. FDA recall Z-1593-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1593-2021. Source: US FDA. Licensed CC0.

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