FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller

Editor's Note

The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller.

The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System has two components—the LifeSPARC Pump and the LifeSPARC Controller.

The LifeSPARC System is used to pump blood through an extracorporeal circuit during full or partial cardiopulmonary bypass in open surgical procedures on the heart or great vessels or during temporary circulatory bypass in open surgical procedures on the aorta or vena cava.

The FDA has received reports of two injuries and no deaths related to this issue.

Distribution dates were December 19, 2019, to November 17, 2022.