Class II — Potential Health Hazard

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

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is Recalled by AtriCure, Inc. Due to There is a potential for a component failure...

Date: September 22, 2016
Company: AtriCure, Inc.
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 AtriCure, Inc. directly.

Affected Products

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Quantity: 298

Why Was This Recalled?

There is a potential for a component failure of the device which could necessitate medical intervention.

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