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Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of IABPs for Potential Electrical Test Failure
Please make sure that you are aware of this recall for testing of System CS100, CS100i and CS300 Intra-aortic Balloon Pumps for electrical testing.
Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices as mentioned in the link provided