FDA Device Intelligence
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Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA product code JOR · Class 3 · Cardiovascular

0
Registered devices
428
Adverse events
2
Recalls
0
510(k) clearances

Recent recalls

DateFirmReason
2010-11-02Terumo Cardiovascular Systems CorporationThe system 8000 roller pumps may fail resulting in a persistent pump stop.
2010-11-02Terumo Cardiovascular Systems CorporationThe system 8000 roller pumps may fail resulting in a persistent pump stop.

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