The FDA has issued a Class I recall for the LifeSPARC open-heart surgery blood pump made by LivaNova. The LifeSPARC system is used in full and partial cardiopulmonary bypass surgery and is comprised of two components, a pump and a controller. The recall affects the controller portion of the unit. A software malfunction was identified that may falsely detect frozen or unresponsive software and trigger the device to enter Critical Failure mode. Once the device enters this mode, the controller screen is cleared and an alarm sounds that cannot be muted or turned off until the user replaces the controller. Failure to properly disconnect the frozen controller and set up the backup controller can result in the pump stopping for an extended period of time. This can cause serious injury or death to the patient.
If you or someone you know suffered a serious injury after undergoing open-heart surgery that included the use of a LifeSPARC blood pump, contact us. Our product liability attorneys have decades of experience fighting large corporations in dangerous medical device litigation and getting people compensation for their injuries. We can provide you with a no-cost case evaluation. Contact us now.