Heart surgery

LivaNova Recall of an Open Heart Surgery Blood Pump Designated as a Class I Event by the FDA

Diving Brief:

  • LivaNova’s recall of 484 LifeSPARC Circulatory Support Systems in the United States has been classified as a Class I event by the Food and Drug Administration
  • LivaNova alerted customers in July to a software malfunction that could cause the pump to shut down for an extended period. The FDA concluded that the defect could cause serious injury or death, leading it to assign the recall to its highest risk category.
  • To date, LivaNova has received 66 misconduct complaints. The FDA has received reports of two injuries and no deaths.

Overview of the dive:

LifeSPARC Circulatory Support Systems are designed to pump blood for up to six hours during open-heart surgery. The device consists of two components, a single-use pump and a controller that serves as the user interface and provides power and electrical signals.

The recall involves the LifeSPARC controller. Due to a fault, the controller may mistakenly detect frozen or unresponsive software and put the device into critical failure mode, according to the FDA. The mode clears the controller screen and triggers an alarm that cannot be muted or disabled.

Although the pump should continue to run at the set speed in critical failure mode, the need to replace the controller can cause problems. The user must follow specific instructions for replacing the controller and shutting down the frozen device before acquiring and configuring the backup controller. If the user fails to complete these steps, the pump may shut down for an extended period while the controller is replaced, the agency said.

Given the risk, LivaNova asked customers to confirm that the pump is running at the set speed if the screen freezes. Users should continue to control speed using the up and down arrows on the controller and follow the instructions in the user manual when replacing the controller, according to the FDA. Sites using the device should ensure that a backup controller is available.