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MC3 Nautilus ECMO Oxygenator
MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Model 48145E · UDI-DI 10854916006901
BYS
Prescription
3
510(k) clearances
177
Adverse events (5 deaths)
2
Recalls
7
Facilities
Description
Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-11 | Mc3 Inc | 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 |
| 2023-10-11 | Mc3 Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.