AtriCure recalls EPi-Sense Guided Coagulation System with Visitrax model CDK-1413 due to potential compromised sterile package seal, which could lead to infection if used. Affected units include specific lots.
The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
AtriCure is recalling its EPi-Sense Guided Coagulation System with Visitrax model CDK-1413 because the sterile package seal might be compromised, increasing infection risk during surgery. This is a serious safety issue for surgical procedures.
The sterile package seal for the system may be compromised, which could lead to infection if the device is used. This is a risk during surgical procedures where the device is intended for coagulating cardiac tissue.
Surgical teams and hospitals using the EPi-Sense Guided Coagulation System with Visitrax model CDK-1413 are most at risk, particularly during cardiac surgery procedures.
Check for the model number CDK-1413 on the device. Affected units include specific lots: 70638, 71332, 89208, 89938, 90624.
Look for the model number CDK-1413 on the device packaging or label.
Confirm the lot number is one of 70638, 71332, 89208, 89938, or 90624.
The sterile package seal may be compromised, which could lead to infection if the device is used during surgery.
The affected model is CDK-1413 with specific lots: 70638, 71332, 89208, 89938, 90624.
Check the model number on the device packaging or label. If it is CDK-1413 and the lot number matches one of the listed numbers, it is affected.
We’ve drafted a message you can send AtriCure to request your refund or repair — edit it as you like.
Subject: Recall Z-1887-2019 — AtriCure AtriCure Hello, I own a AtriCure that is covered by recall Z-1887-2019 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.
