Due to a shortage of alternatives to Getinge cardiovascular devices, the FDA has provided a series of recommendations for doctors who have to continue to using the products, which have been linked to patient injuries and deaths.
The FDA is warning that the devices can shut down unexpectedly, but issued recommendations for their continued use by medical providers
Similar issues have led to a number of other Cardiosave balloon pump recalls in recent years, due to problems that may lead to severe injury or death.
The manufacturer has received more than 100 complaints of malfunctions due to blood infiltration of the intra-aortic balloon pumps.
Manufacturer warns the aortic balloon pump may fail prematurely due to rapid battery depletion, leading to a disruption in treatment.
Problems with more than 4,300 devices could lead to serious injuries or deaths, the FDA warns.
