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LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure

LivaNova (TandemLife) is recalling the LifeSPARC Controller, part of the LifeSPARC System, due to a software malfunction that may trigger the device to enter Critical Failure mode—clearing the controller screen and issuing an alarm that cannot be muted or turned off. This is an addition to a previous recall. The current recall provides information about a software update now available to address this issue, increases the number of affected devices, and adds more reported complaints.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Questions?

Customers with questions about this recall should contact their LivaNova representative or LivaNova Customer Quality at LivaNova.FSCA@livanova.com.