COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Check against the official notice below — it lists the full affected range.
AtriCure, Inc. is recalling 765 units of the COBRA FUSION 150 Ablation System (Catalog # 700-001MI) distributed internationally across multiple U.S. states and 13 countries in Europe and the Middle East. The recall applies to all lots within the product's expiration date, identified by UDI 00818354013016.
The recall was initiated because there is a potential for patients undergoing ablation with this device to experience an elevated risk for thromboembolism (TE) during stand-alone off-pump procedures where cardiopulmonary bypass (CPB) was not utilized. The source document does not specify a remedy or 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: 765 units Lot/code info: UDI - 00818354013016 Lot Numbers - All lots within expiry
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.