Another Class I Recall for Getinge Intra-Aortic Balloon Pump

The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/ Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP), this time for the potential of the device to overheat and shut down.

The class I recall comes after the company issued two “medical device correction” letters on July 31 pointing out several “system conditions.” The six issues reported in the letters are autofill alarm, gas loss and gas gain alarm, fiber optic damage, docking/power battery failure, poor or no electrocardiogram signal and system over-temperature.

The company and the FDA have noted that the recall is a voluntary correction — not a product removal — for 4,586 IABPs. The various models of the Cardiosave Hybri and Cardiosave Rescue were distributed between March 6, 2012, and May 19.

Between Jan. 1, 2021, and June 2, Getinge/Maquet/Datascope has reported 213 complaints, including four injuries and one death.

Read the July 31 company voluntary recall letters here and here.

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