LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller's monitoring feature to wrongly enter critical failure mode, causing the pump to stop working. The FDA has identified this as a Class I recall. To date, LivaNova has received 66 complaints about the fault. The FDA has received reports of two injuries and no deaths.

The LifeSPARC System is intended to pump blood through an extracorporeal circuit for periods lasting less than 6 hours for full or partial circulatory support.The LifeSPARC System has two components: the LifeSPARC Pump and the LifeSPARC Controller. The LifeSPARC Pump is a single-use pump, and the LifeSPARC Controller provides the interface between the pump and the user, as well as the power and electrical signals to drive the pump.

LivaNova asked customers to confirm that the pump operates at the set speed if the screen freezes and a backup controller is available when the device is used.