FDA Device Intelligence
HomeDevice types › BYS

Oxygenator, Long Term Support Greater Than 6 Hours

FDA product code BYS · Class 2 · Cardiovascular

10
Registered devices
178
Adverse events
2
Recalls
3
510(k) clearances

Devices with this code

Recent 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 r
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 r

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.