FDA issues new recall for circulatory support system after software update
The U.S. Food and Drug Administration (FDA) has announced a new recall for LivaNova’s LifeSPARC controller, part of its LifeSPARC advanced circulatory support solution. LivaNova originally recalled the LifeSPARC controller in 2022 due to a software malfunction that was causing it to mistakenly enter “critical failure” mode, clear the controller screen and set off an alarm that could not be muted or stopped. The LifeSPARC device was designed to continue running when in critical failure mode—but only if the user replaces the controller before disconnecting the pump.
Since that issue was discovered, LivaNova has released a new software update that provides a solution. The FDA issued this latest recall to ensure all controllers were successfully updated to the new software version, version 1.1.5. According to LivaNova, the percentage of devices that have been successfully updated is already approaching 100%.
More details about this issue are available on the FDA’s updated advisory and the LivaNova website. Customers with questions are advised to contact either their LivaNova representative directly or send a message to this email address.
Additional context on this latest LifeSPARC recall
The original Class I recall about this issue came after a total of 66 complaints—and two patient injuries—were reported. It included 484 devices distributed from December 2019 to the time of the recall. The recall was first initiated in July 2022.
When this recall was first announced, the FDA warned that the issue could result in an extended pump stop, which “may cause serious injury or death to the patient.”
One key detail about this recall is that the FDA did not require all LifeSPARC advanced circulatory support solutions to be removed from the field or returned to the distributor. The FDA agreed to LivaNova’s strategy of providing a software update that would fix the issue once successfully installed.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.