# FDA recall Z-0077-2022

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2021-09-07.

## Product

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS,  REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

## Reason for recall

Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain  a 9mm x 29 mm x 135 cm device.

## Distribution

International distribution to the countries of Italy & Lebanon.

## Key facts

- **Recall number:** Z-0077-2022
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-07
- **Report date:** 2021-10-20

- **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-0077-2022

## Citation

> AI Analytics. FDA recall Z-0077-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0077-2022. Source: US FDA. Licensed CC0.

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