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Terumo® Advanced Perfusion System 1

Terumo Cardiovascular Systems Corporation · Model 804981 · UDI-DI 00886799000830

DWBDTQ Prescription
1
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities

Description

Cable used to connect the CDI data module to the intended CDI device.

Recalls

DateFirmReason
2011-10-21Terumo Cardiovascular Systems CorporationTerumo 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
2011-08-29Terumo Cardiovascular Systems CorporationThe Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

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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.