AtriCure, Inc. recalls COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002

Recall date

January 22, 2019

Source

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

Recall number

Z-0829-2019

FDA classification

Class II

Brand / firm

AtriCure, Inc.

Sold / distributed

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwa…

Why it was recalled

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

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

What was recalled

COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002