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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During 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. While the LifeSPARC Pump should continue to run at the set speed with the allowance of manual speed adjustment in Critical Failure mode, the user has to replace the controller, using instructions from the Operations Manual, before disconnecting the pump from the frozen controller. 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.

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 regarding this recall should contact their LivaNova representative or LivaNova Customer Quality at LivaNova.FSCA@livanova.com.