Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support Recalled by Mc3 Inc Due to May have increased water path restriction within the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mc3 Inc directly.
Affected Products
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Quantity: 299 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mc3 Inc
Mc3 Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report