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CAPIOX

TERUMO CORPORATION · Model CX*BT05 · UDI-DI 04987350705693

KRL Prescription

510(k) clearances

148

Adverse events (2 deaths)

Recalls

Facilities

Description

CAPIOX Bubble Trap

Recalls

Date	Firm	Reason
2010-10-15	Terumo Cardiovascular Systems Corporation	Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the
2007-09-19	Terumo Cardiovascular Systems Corp	False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
2007-09-19	Terumo Cardiovascular Systems Corp	False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
2007-09-19	Terumo Cardiovascular Systems Corp	False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

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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.