FDAOctober 11, 2023device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
mc3
UPCs
1085491600687110854916006895
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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