# FDA recall Z-1591-2021

> **Boston Scientific Corporation** · Class I · device recall initiated 2021-04-12.

## Product

VICI VENOUS STENT System    Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

## Reason for recall

The firm has received reports of stent migration after implantation

## Distribution

Worldwide - US Nationwide Distribution

## Key facts

- **Recall number:** Z-1591-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-12
- **Report date:** 2021-05-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2021

## Citation

> AI Analytics. FDA recall Z-1591-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1591-2021. Source: US FDA. Licensed CC0.

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