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Cardiosave system - hybrid & rescue intra-aortic balloon pump
Official notice
4 Jan 2023
Last checked
4 Jan 2023
An official Health Canada notice concerns Cardiosave system - hybrid & rescue intra-aortic balloon pump. Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood entering into the Cardiosave IABP when therapy is provided with a perforated intra-aortic balloon catheter. Recall start date: December 21, 2022 Published 2023-01-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72511
Official notice
2023-01-04
The hazard
The hazard
Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood entering into the Cardiosave IABP when therapy is provided with a perforated intra-aortic balloon catheter. Recall start date: December 21, 2022
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Brand: Datascope, Cardiosave System - Hybrid Rescue Intra-aortic Balloon Pump.
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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