(Reuters) – The U.S. Food and Drug Administration on Friday classified the recall of LivaNova’s device that controls a blood-pumping system at its most serious type, citing that their use could cause serious injuries or death.
The medical device company recalled 589 units of the LifeSPARC system’s controller, through the period of Dec. 19, 2019 to Nov. 17, 2022, for a software update to address a previously known malfunction.
The controller’s software malfunction may trigger the device to enter critical failure mode causing the pump to stop for an extended time period, the FDA said, which may lead to serious injury or death of the patient.
LivaNova’s recall is in addition to a previous withdrawal of 484 units due to the same issue. The company has reported 66 complaints and the FDA has received reports of two injuries due to this issue.
On Dec. 5, LivaNova started notifying customers about the software update’s availability to resolve the critical failure issue. The UK-based manufacturer did not immediately respond to a Reuters request for comment outside of business hours.
(Reporting by Sriparna Roy and Aditya Samal in Bengaluru; Editing by Krishna Chandra Eluri)
