Jan 27 (Reuters) – The U.S. Food and Drug Administration on Friday classified the recall of LivaNova’s device that controls a blood pumping system as the most serious. , citing that their use can cause serious injury or death.
The medical device company recalled 589 LifeSPARC system controller units, during the period from December 19, 2019 to November 17, 2022, for a software update to address a previously known malfunction.
Controller software malfunction can cause the device to enter critical failure mode that causes the pump to stop for an extended period of time, the FDA said, which could lead to serious injury or death of the patient.
The LivaNova recall is in addition to an earlier recall of 484 units due to the same issue. The company reported 66 complaints and the FDA received reports of two injuries due to this issue.
On December 5, LivaNova began notifying customers of the availability of a software update to resolve the critical failure issue. (Reporting by Sriparna Roy and Aditya Samal in Bengaluru; Editing by Krishna Chandra Eluri)
