LivaNova’s Recall of the LifeSPARC System Is Class I

LivaNova’s July 21 recall of its LifeSPARC system has been identified by the FDA as Class I.
 
LIFESPARC pumps blood through an extracorporeal circuit for periods less than six hours. This can be used to provide full or partial cardiopulmonary bypass during open surgical procedures on the heart of great vessels. It can also be used for temporary circulatory bypass for diversion of flow around a planned circulatory pathway disruption needed for open procedures on the aorta or vena cava.
 
The LifeSPARC System has two components: the LifeSPARC Pump and the LifeSPARC Controller.  The LifeSPARC Pump is a single-use pump, and the LifeSPARC Controller provides the interface between pump and user, as well as power and electrical signals to drive the pump.
 
LivaNova (TandemLife) recalled the LIFESPARC controller due to a software malfunction that may cause the monitoring feature to erroneously detect frozen or unresponsive software and trigger Critical Failure mode, which clears the controller screen and issues an alarm that can’t be muted or turned off.
 
The LifeSPARC pump will still run at the set speed with allowance of manual speed adjustment, the user must replace the controller using instructions from the Operations Manual before disconnecting the pump from the frozen controller. If specific instructions aren’t followed and the frozen controller is powered off before getting and setting up the backup controller, the pump can stop for an extended amount of time during replacement. This can cause serious injury or death.
 
The affected products were distributed between December 19, 2019 and the present. 484 device were recalled in the U.S. According to FDA, LivaNova reported 66 complaints, two injuries, and no deaths thus far related to the issue.