LifeSPARC

2022: Recall of defective cardiopulmonary devices due to problematic software

In early October 2022, LivaNova recalled 484 LifeSPARC circulatory support systems from the United States due to a software malfunction that could cause the pump to stop for a long period of time.

In July 2022, LivaNova warned consumers about the malfunction. The FDA concluded that the malfunction could lead to serious injury or death, leaving the recall as the highest risk category. As of Oct. 7, 2022, LivaNova received 66 complaints about the fault, and the FDA received reports of two injuries and no deaths.

LifeSPARC

LifeSPARC circulatory support systems are designed to pump blood for six hours during open heart surgery. The device consists of two components: a disposable pump and a controller that serves as a user interface and provides power and electrical signals.

The recall applies to the LifeSPARC controller. According to the FDA, due to a malfunction, the controller may erroneously detect frozen or unresponsive software and put the device into critical failure mode. This mode clears the controller screen and triggers an alarm that cannot be turned off or off. Although the pump must continue to operate at a given speed in critical failure mode, the need to replace the controller can cause problems. Before purchasing and configuring a backup controller, the user must follow the special instructions for replacing the controller and turn off the power of the frozen device. If the user does not perform these actions, the pump can stop for a long period of time until the controller is replaced, the agency said.

Given the risk, LivaNova asked customers to make sure the pump works at a given speed if the screen freezes. Users should continue to adjust speed with up and down arrows on the controller and follow instructions in the operating manual when replacing the controller, the FDA said.^[1]

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