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Sarns™ Modular Perfusion System 8000
Terumo Cardiovascular Systems Corporation · Model 16402 · UDI-DI 00886799000182
DWB
Prescription
1
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities
Description
Roller Pump, 115V, System 8000
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 shipped to a single cu |
| 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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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.
