FDA Issues Update on LivaNova Recall of Blood Pumping System
The FDA has provided an update on LivaNova (TandemLife)’s Dec. 5, 2022, recall of its LifeSPARC System, deeming it a Class 1 recall because of the risk of serious injury or death.
Used for cardiopulmonary bypass surgery, the system pumps blood through an extracorporeal circuit for surgeries lasting six hours or less. The system was previously recalled for a software malfunction in July 2022 with a corrective software update issued in December 2022.
The software update “may erroneously detect frozen or unresponsive software and trigger the device to enter Critical Failure mode — clearing the controller screen and issuing an alarm that cannot be muted or turned off,” the agency said.
The 589 affected products were distributed between Dec. 19, 2019, and Nov. 17, 2022. The FDA has received reports of two injuries, but no deaths related to this issue.