FDA Provides Update on Recall of LifeSPARC Systems
The FDA issued an update on LivaNova’s July 21 recall of its LifeSPARC devices, deeming it a Class 1 recall because of the risk of serious injury or death.
The system, which includes a single-use pump and a controller, is used to pump blood through an extracorporeal circuit during open surgical procedures on the heart or great vessels.
The recall was prompted by a potential software malfunction that could cause the device to unintentionally stop working, the FDA said.
The 484 affected products were distributed from Dec. 19, 2019 to the present. There have been 66 complaints and two injuries associated with the issue, the agency said.