FDA Deems Cardiosave Intra-Aortic Balloon Recall Class I

The FDA has deemed the Jan. 9 recall of Datascope’s Cardiosave Hybrid intra-aortic balloon pump (IABP) and Rescue IABP as Class I, the most serious type of recall, as use of the devices may cause serious injuries or death.

The pumps are electromechanical systems used to inflate and deflate intra-aortic balloons and are used for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

Datascope, a subsidiary of Germany-based Getinge, sent customers an Urgent Medical Device Correction letter on Feb. 7, warning that the coiled cable connecting the display and base on some units may fail, causing a shutdown, without a warning or alarm to alert the user. Shutdown of the pump can lead to unstable blood flow, organ damage and/or death.

The potential issue affects units distributed before July 24, 2017.