Class II — Potential Health Hazard

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

Cryo Module Accessories Domestic CMA-OUS Recalled by AtriCure, Inc. Due to AtriCure has identified certain lots of tank hose...

Date: November 28, 2023
Company: AtriCure, Inc.
Status: Ongoing
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 AtriCure, Inc. directly.

Affected Products

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

Quantity: 35

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AtriCure, Inc.

AtriCure, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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