AtriCure, Inc. recalls AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's le…

Recall date

September 22, 2016

Source

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

Recall number

Z-0377-2017

FDA classification

Class II

Brand / firm

AtriCure, Inc.

Sold / distributed

Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland

Why it was recalled

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

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

What was recalled

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.