LivaNova is recalling the LifeSPARC Controller—which is part of the LifeSPARC System—due to a software update being available to address a previous software malfunction that may erroneously detect frozen or unresponsive software and trigger the device to enter critical failure mode.
When the device enters critical failure mode, it clears the controller screen and issues an alarm that cannot be muted or turned off. This recall is an addition to a previous recall for the same issue, LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The FDA has received two injuries and no deaths due to this issue.
The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than six hours for the purpose of providing either:
- Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessel
- Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical 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 the power and electrical signals to drive the pump.
The current recall provides information about a software update now available to address this issue. This recall affects 589 devices in the U.S.