FDA announces Class I recall of circulatory support system after 66 complaints, 2 patient injuries
The U.S. Food and Drug Administration (FDA) has announced LivaNova is recalling the LifeSPARC controller, part of its LifeSPARC advanced circulatory support solution, due to a software malfunction. The LifeSPARC device was designed to pump a patient’s blood through an extracorporeal circuit during certain cardiovascular procedures or divert the flow of blood around a planned disruption.
This is a Class I recall, which means “use of these devices may cause serious injuries or death.” There have been 66 complaints and two injuries so far related to this issue. No deaths have been reported. The recall includes 484 devices distributed from December 2019 to the present day.
The malfunction occurs when the LifeSPARC controller mistakenly detects frozen or unresponsive software, triggering the device to enter “critical failure” mode and setting off an alarm that cannot be muted or stopped. The LifeSPARC device was designed to continue running when in critical failure mode—but only if the user replaces the controller before disconnecting the pump.
“If the user does not follow these specific instructions and powers off the frozen controller prior to acquiring and setting up the backup controller, the pump may stop for an extended period of time during the replacement process,” according to an advisory posted on the FDA’s website. “An extended pump stop during use may cause serious injury or death to the patient.”
LivaNova has advised customers to check their LifeSPARC systems to ensure they are operating properly and that, if the screen ever freezes, the pump speed is staying consistent. Any controllers that enter critical failure mode should be replaced with a new controller by following the detailed instructions included in the device’s instructions. An external flow measurement system may be needed while the controller is being replaced. Sites using the device are also advised to keep a backup controller—including the dock, batteries and a power cord—on hand.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.