Failing batteries to hold charge and unexpected stoppage leads to their recall by Maquet/Datascope. It is Class 1, most serious type recall as per the FDA.
As per the company officials, they were aware of death of five patients since 2016. However, their relation with device shutting down was not determined.
Cardiosave Hybrid IABP, CS100/100iIABP and Cardiosave Rescue IABP, CS300 IABP are some of the affected medical device models.
Intra-aortic balloon pumps are cardiac assist devices to treat patients with heart failure complications and acute coronary syndrome.
Mr Vinod Arora, Principal Advisor, IGMPI
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