Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35

Hazard

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

Details from the source

Reason for recall: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. Distribution: Worldwide - US Nationwide distribution. Quantity: 11574 units (5413 US, 6161 OUS) Lot/code info: All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449; Model: 0998-00-0800-36, UDI: 10607567114187; Model: 0998-UC-0800-32, UDI: N/A; Model: 0998-UC-0800-34, UDI: N/A; Model: 0998-UC-0800-35, UDI: N/A; Model: 0998-UC-0800-36, UDI: N/A; Model: 0998-UC-0800-45, UDI: N/A; Model: 0998-UC-0800-65, UDI: N/A;

UPC codes

10607567109053, 10607567111117, 10607567109008, 10607567111940, 10607567109107, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432, 10607567112312, 10607567108407, 10607567113449, 10607567114187

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.