AtriCure recalls COBRA FUSION 150 Ablation System (all lots) due to potential elevated risk of TE in off-pump cardiac procedures without CPB. Learn what to do.
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 all lots because it may increase the risk of TE (thromboembolism) during certain heart surgery procedures where cardiopulmonary bypass isn't used. This is a serious risk for patients undergoing specific cardiac ablation treatments.
The device may cause blood clots to travel to the brain or other organs during heart surgery when cardiopulmonary bypass isn't used. This happens because the system's design doesn't account for blood flow changes in off-pump procedures, potentially leading to thromboembolism.
Patients undergoing cardiac ablation procedures without cardiopulmonary bypass (CPB) are most at risk. Healthcare providers using the COBRA FUSION 150 system for off-pump procedures may need to take extra precautions.
Check for the COBRA FUSION 150 Ablation System with catalog number REF 700-001. All lots within the product's expiration date are affected.
Look for the lot number on the device packaging or label to confirm if it's affected.
Reach out to AtriCure directly for guidance on next steps if you have the affected device.
The recall indicates a potential risk for TE in specific off-pump procedures without CPB. The device may not be safe for all cardiac procedures.
Check the lot number and contact AtriCure for guidance. The recall does not specify a return or replacement process.
The recall mentions a potential elevated risk of TE, which could lead to serious complications like stroke or organ damage.
We’ve drafted a message you can send AtriCure to request your refund or repair — edit it as you like.
Subject: Recall Z-0830-2019 — AtriCure AtriCure Hello, I own a AtriCure that is covered by recall Z-0830-2019 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.
