AtriCure recalls COBRA FUSION 150 Ablation System (Catalog # 700-001S) due to potential elevated risk of TE during off-pump cardiac procedures. All units are affected.
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.
AtriCure is recalling its COBRA FUSION 150 Ablation System (Catalog # 700-001S) because it may increase the risk of TE (thromboembolism) for patients undergoing certain heart procedures without cardiopulmonary bypass. This is a serious risk that requires immediate attention from medical users.
The device may cause blood clots to travel to the brain or other organs during heart procedures where cardiopulmonary bypass is not used. This happens because the system's design can lead to elevated thromboembolism risk in specific surgical contexts.
Medical professionals using the COBRA FUSION 150 Ablation System for cardiac procedures without cardiopulmonary bypass are affected. Patients undergoing these procedures face the highest risk of thromboembolism.
Check for the COBRA FUSION 150 Ablation System with Catalog # 700-001S. All units are affected regardless of lot number or expiration date.
Immediately discontinue use of the COBRA FUSION 150 Ablation System (Catalog # 700-001S) if it is in your possession.
Yes, all units of the COBRA FUSION 150 Ablation System with Catalog # 700-001S are affected.
The device may increase the risk of thromboembolism (TE) for patients undergoing ablation procedures without cardiopulmonary bypass.
Check for the COBRA FUSION 150 Ablation System with Catalog # 700-001S. All units are affected regardless of lot number or expiration date.
We’ve drafted a message you can send AtriCure to request your refund or repair — edit it as you like.
Subject: Recall Z-0831-2019 — AtriCure AtriCure Hello, I own a AtriCure that is covered by recall Z-0831-2019 from AtriCure. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
