FDA classifies recall of LivaNova's blood-pumping system controller as most serious
Yahoo! Finance
The U.S. Food and Drug Administration on Friday classified the recall of LivaNova's device that controls a blood-pumping system at its most serious type, citing that their use could cause serious injuries or death. The medical device company recalled 589 units of the LifeSPARC system's controller, through the period of Dec. 19, 2019 to Nov. 17, 2022, for a software update to address a previously known malfunction. The controller's software malfunction may trigger the device to enter critical f...
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