Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atrium ADVANTA VXT Vascular Graft Recalled by Atrium Medical Corporation Due to The product package may potentially contain a mismatched...

Date: August 25, 2021
Company: Atrium Medical Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.

Affected Products

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.

Quantity: 28 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Atrium Medical Corporation

Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report