Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)

Issue 1:

There have been reports of IABP units losing the ability to charge batteries in one or both bay slots due to a failure in the power management board charging path circuitry due to damage to the component from a previous electrical surge. Therapy may be interrupted if batteries fail to charge and the device is disconnected from ac power. Low battery alarms may alert the user to the issue prior to interruption of therapy.

Issue 2:

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the power management board and/or solenoid board. This issue may lead to an unexpected interruption of therapy.

Recall start date: June 9, 2023