Mc3 recalls Nautilus Smart ECMO modules with Balance Biosurface due to potential hypothermia from reduced heat exchange. Affected units have specific serial numbers and product codes.
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
Mc3 is recalling Nautilus Smart ECMO modules that may cause hypothermia due to poor heat exchange. This risk occurs because the device might not properly regulate blood temperature during use.
The module may have increased water path restriction in the heat exchanger, reducing blood temperature regulation. This can cause hypothermia if the device fails to transfer heat properly during use.
Healthcare professionals using the Nautilus Smart ECMO module for extracorporeal life support are most at risk. Patients receiving this life support treatment could experience hypothermia if the device fails.
Check if your device has serial numbers between 481022923 and 481025039. Product numbers 48135 and 48135E are also affected. The device is used for blood oxygenation and temperature regulation in life support.
Look for serial numbers between 481022923 and 481024039 on the device.
The device may cause hypothermia due to reduced heat exchange performance, which can lead to inadequate blood temperature regulation.
Check if your device has serial numbers between 481022923 and 481024039 or product numbers 48135 or 48135E.
The recall does not specify a remedy, so contact Mc3 Inc for further instructions.
We’ve drafted a message you can send Mc3 to request your refund or repair — edit it as you like.
Subject: Recall Z-1310-2024 — Mc3 Mc3 Hello, I own a Mc3 that is covered by recall Z-1310-2024 from Mc3. 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.
