Levitronix Recalls Blood Pumping System
Levitronix has recalled its CentriMag extracorporeal blood pumping system and its primary and backup consoles.
The system temporarily replaces the function of the heart and lungs and maintains the appropriate circulation of blood and oxygen levels in the body during surgical procedures. It was recalled because its use with another electrosurgery device could result in stoppage of the pump, leading to serious injury or death.
The company issued a device correction letter March 17 to its U.S. distributor requesting that it contact its customers. The firm recently updated the letter, informing customers not to use the system with the Valleylab Force FX-C or SSE2L electrosurgery device, according to the FDA.
The recall is an interim fix while the firm investigates the source of the problem. More information is available at www.levitronix.com/Documents/Medical_us/Dear_Doctor-Final.pdf.