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Cardiosave Hybrid IABP (Datascope) – Helium Tank Leak Risk (2023)

Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

Moderate

FDAFeb 7, 2023Nationwide• Datascope Corp.

Cardiosave Hybrid (Datascope) – Communication Failure Issue (2023)

Laceration Risk

An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.

Moderate

FDAFeb 7, 2023Nationwide

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Cardiosave Hybrid IABP (Datascope) – Helium Tank Leak Risk (2023)

Cardiosave Hybrid (Datascope) – Communication Failure Issue (2023)

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Cardiosave Rescue (Datascope) – Communication Failure Issue (2023)

Cardiosave Hybrid IABP (Datascope) – Unexpected Shutdown Risk (2023)

Cardiosave Rescue (Datascope) – Helium Tank Leak Risk (2023)

Cardiosave Hybrid IABP (Datascope) – Helium Regulator Failure (2023)

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