FDA classifies recall of LivaNova's blood-pumping system controller as most serious

Livanova

27/01/2023 17:55

Jan 27 (Reuters) - The U.S. Food and Drug Administration
on Friday classified the recall of LivaNova's  LIVN.O  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)
 ((Sriparna.Roy@thomsonreuters.com;))