Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue IABPs because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board.
Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board .
"Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury , and death," the US Food and Drug Administration says inThe FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
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