Medical Device Recall: NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 4
Mc3 Inc · October 11, 2023
Reason for Recall
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
Product Description
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
188 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1310-2024
Status: ongoing
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