The US health regulator claimed that the device could reach critical failure mode due to a problem in the controller's software, which forces the pump to stop for a long time
The US FDA Building 66. (Credit: The U.S. Food and Drug Administration from Wikimedia Commons)
The US Food and Drug Administration (FDA) has classified LivaNova’s recall of a device that controls a blood-pumping system as Class I, which is the most serious type of recall that could cause serious adverse health consequences or death.
The American medical device manufacturer recalled 589 units of the controller for the LifeSPARC system between 19 December 2019 and 17 November 2022. The recall was intended to update the software of the controller to fix a known malfunction.
LifeSPARC is said to be a next-generation advanced circulatory support (ACS) pump and controller system that is designed to eliminate the complexity associated with ECMO devices.
According to the US health regulator, the device could reach critical failure mode due to a problem in the controller’s software, which forces the pump to stop for a long time.
The FDA claimed that stopping of the pump may cause grave injury or death to the patient.
The latest recall of LivaNova’s products follows the previous recall for the same problem that included 484 units. Due to this problem, the company has received 66 complaints, and the FDA has been informed of two injuries, Reuters reported.
In December last year, LivaNova began informing consumers about the availability of the software update to fix the major failure problem.
The US FDA categorises recalls into a numerical category, I, II, or III to reflect the relative level of health risk that the recalled product poses.
Last November, LivaNova secured the FDA 510(k) approval for extracorporeal membrane oxygenation (ECMO) for its LifeSPARC system.
The LifeSPARC system is a centrifugal pump device that supports the circulation of patients’ blood and is said to offer a simplified user interface and a simple navigation panel.