AtriCure recalls its COBRA FUSION 150 Ablation System (International) due to potential elevated risk of thromboembolism in off-pump cardiac procedures without cardio pulmonary bypass.
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 for international use because it may increase the risk of blood clots in patients having heart procedures without heart-lung machines. This is a serious concern for medical professionals performing certain surgeries.
The device may increase the risk of blood clots (thromboembolism) during heart procedures where the patient's heart-lung machine is not used. This happens when the device is used alone without the heart-lung support system.
Medical professionals using the COBRA FUSION 150 Ablation System for international cardiac procedures are most at risk. Patients undergoing these specific procedures may face elevated blood clot risks.
Check for the COBRA FUSION 150 Ablation System with catalog number 700-001MI. This product is sold internationally and includes all lots within expiration dates.
Identify the product by catalog number 700-001MI and check if it's used internationally.
The recall indicates a potential risk of blood clots during specific procedures, so it's not recommended for use without further evaluation.
The recall does not specify a remedy, so contact AtriCure directly for guidance.
The recall mentions a potential elevated risk of blood clots, but does not specify if this can cause serious injury in normal use.
We’ve drafted a message you can send AtriCure to request your refund or repair — edit it as you like.
Subject: Recall Z-0832-2019 — AtriCure AtriCure Hello, I own a AtriCure that is covered by recall Z-0832-2019 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.
