# FDA recall Z-2589-2021

> **Atrium Medical Corporation** · Class II · device recall initiated 2021-08-25.

## Product

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

## Reason for recall

The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.

## Key facts

- **Recall number:** Z-2589-2021
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-25
- **Report date:** 2021-10-06
- **Termination date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2021

## Citation

> AI Analytics. FDA recall Z-2589-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2589-2021. Source: US FDA. Licensed CC0.

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