AtriCure, Inc. recalls COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Recalled Product
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Hazard / Issue
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.
Issued by
FDA
Affected States: 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
Lot/Code Info: UDI - 00818354012811 Lot Numbers - All lots within expiry
View official government recall
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