AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

Recall date

November 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0927-2024

FDA classification

Class II

Brand / firm

AtriCure, Inc.

Sold / distributed

US Nationwide. Brazil, Canada, Japan, Taiwan

Why it was recalled

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053