AtriCure recalls COBRA FUSION 50 Ablation System (Catalog # 700-002) due to potential elevated risk of TE in off-pump cardiac procedures without CPB. Affected units have UDI 00818354012811 and all lots within expiry.
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 50 Ablation System (Catalog # 700-002) because it may increase the risk of TE (thromboembolism) during certain heart surgery procedures where cardiopulmonary bypass is not used. This recall affects patients undergoing ablation procedures without CPB.
The device may increase the risk of thromboembolism (TE) during heart surgery when cardiopulmonary bypass is not used. This occurs because the ablation system is designed for off-pump procedures where blood flow is not supported by external machinery.
Patients undergoing ablation procedures without cardiopulmonary bypass (CPB) are most at risk. The recall applies to all units with the specified catalog number and UDI.
Check for the catalog number 700-002 and unique device identifier (UDI) 00818354012811. All units within the product's expiry date are affected.
Identify the catalog number (700-002) and UDI (00818354012811) on the device label.
The recall indicates a potential elevated risk of TE during specific procedures without CPB. The device may not be safe for off-pump ablation procedures without cardiopulmonary bypass.
The recall does not specify a remedy, so there is no action required beyond checking device details. Contact AtriCure for further guidance.
Check for catalog number 700-002 and UDI 00818354012811 on the device label. All units within the product's expiry date are affected.
We’ve drafted a message you can send AtriCure to request your refund or repair — edit it as you like.
Subject: Recall Z-0829-2019 — AtriCure AtriCure Hello, I own a AtriCure that is covered by recall Z-0829-2019 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.
