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AtriCure, Inc. recalls COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Recalled February 20, 2019 · FDA recall Z-0829-2019 · AtriCure
Hazard
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. · FDA Class II
Units
1288 units
Sold at
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, Kuwait, Belgium and Latvia
Description
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.
Product
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Manufacturer(s)
AtriCure, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →