COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Check against the official notice below — it lists the full affected range.
AtriCure, Inc. is recalling 1,288 units of the COBRA FUSION 50 Ablation System (Catalog # 700-002) distributed across 37 U.S. states and 13 international countries. The recall affects all lot numbers within expiry for this device, identified by UDI 00818354012811.
The recall is due to a potential risk of thromboembolism (TE) in patients undergoing ablation with this system during stand-alone off-pump procedures where cardiopulmonary bypass (CPB) was not used. The source does not specify a remedy or recommended corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Quantity: 1288 units Lot/code info: UDI - 00818354012811 Lot Numbers - All lots within expiry
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.