FDA Issues Update on Recall of Datascope/Getinge Balloon Pumps

For the second time in less than a month, the FDA issued an update on Datascope/Getinge’s Jan. 9 Class 1 recall of its Cardiosave Hybrid and Rescue intra-aortic balloon pumps, citing another potential failure that could cause severe injury or death.

The electromechanical pumps are used to inflate and deflate intra-aortic balloons used for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. The potentially affected devices were distributed between March 6, 2012 and Jan. 13.

The recalled systems could lose communication between the printed circuit board assembly (PCBA) and the separate PCBA for the video generator, potentially causing a shutdown without a warning or alarm. An unexpected pump shutdown could lead to unstable blood flow, organ damage and/or death, the FDA said.

Once the error occurs, one or both of the PCBAs musts be replaced before the device will work again, the agency said.

The FDA previously classified the company’s recall of the device as a Class 1 recall on March 17 for risk of unexpected shut-down from a coiled cord connection.

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