FDA: Class I recall of LivaNova’s LifeSPARC System

Editor's Note

The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious.

The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a software malfunction.

The LifeSPARC System is used to pump blood through an extracorporeal circuit during full or partial cardiopulmonary bypass or during temporary circulatory bypass.

To date, there have been 66 complaints to LivaNOVA, and the FDA has received reports of two injuries and no deaths associated with this issue.

Distribution dates were December 19, 2019 to present.