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Nautilus VF Oxygenator Cable

MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Model 58130 · UDI-DI 10850007732322

BYS Prescription
1
510(k) clearances
177
Adverse events (5 deaths)
2
Recalls
7
Facilities

Description

Power and data cable for the Nautilus VF ECMO Oxygenator

Recalls

DateFirmReason
2023-10-11Mc3 IncMay 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
2023-10-11Mc3 IncMay 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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Data 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.