Datascope Corp. is recalling 28 units of the Cardiosave IABP Lithium-Ion Battery Charging Station because a protruding screw in the left battery bay can prevent batteries from being fully inserted. This defect prevents proper charging of the batteries used to power the Cardiosave Intra-Aortic Balloon Pump (IABP) when it is not connected to a wall outlet. The right bay of the charger is not affected by this issue, but any unit with the affected serial numbers should be checked and serviced.
If the battery does not charge properly due to the protruding screw, the Intra-Aortic Balloon Pump may have insufficient power during patient transport or power outages, potentially leading to a life-threatening interruption in cardiac support.
Quantity: 28 units (20 US, 8 OUS). The left battery bay is affected; the right bay is not.
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Sources: FDA iRES · Raw API Response
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