medical Class I Updated 2023-09-06

Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu

Recalled Product

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Hazard / Issue

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449, Model: 0998-UC-0800-75, UDI: N/A; Model: 0998-UC-0800-83, UDI: N/A; Model: 0998-UC-0800-85, UDI: N/A;
View official government recall

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