Dive Brief:
- LivaNova’s recall of 484 LifeSPARC circulatory support systems from the U.S. has been labeled as a Class I event by the Food and Drug Administration
- LivaNova alerted customers in July to a software malfunction that can result in the pump stopping for an extended period of time. The FDA concluded the fault may cause serious injuries or death, leading it to assign the recall to its highest risk category.
- To date, LivaNova has received 66 complaints about the fault. The FDA has received reports of two injuries and no deaths.
Dive Insight:
LifeSPARC circulatory support systems are designed to pump blood for up to six hours during open-heart surgery. The device features two components, a single-use pump and a controller that serves as the user interface and provides power and electrical signals.
The recall covers the LifeSPARC Controller. Because of 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 causes an alarm that cannot be muted or turned off.
While 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 needs to follow specific instructions for replacing the controller with a backup. A LivaNova spokeswoman noted the company has published a guide to replacing the controller on its website and has sent documentation to all of its customers. If the user fails to perform those steps, the pump may stop for an extended period of time while the controller is replaced, the FDA said.
This article was updated with information from LivaNova clarifying the steps users of the device should take to ensure it continues to operate in the event of a controller failure.
