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Pump, Blood, Cardiopulmonary Bypass, Roller Type
FDA product code DWB · Class 2 · Cardiovascular
18
Registered devices
1,832
Adverse events
2
Recalls
21
510(k) clearances
Devices with this code
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-21 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was sh |
| 2011-08-29 | Terumo Cardiovascular Systems Corporation | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. |
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