Levitronix has recalled its CentriMag extracorporeal blood pumping system and its primary and backup consoles because its use with another electrosurgery device could result in stoppage of the pump, leading to serious injury or death.
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.
The Zurich, Switzerland-based Levitronix issued a device correction letter March 17 to its U.S. distributor requesting that it contact its customers, specifically cardiothoracic surgery chiefs.
On July 24, the company 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 Valleylab Force FX-C electrosurgery unit triggered a motor failure alarm and stoppage of the CentriMag blood pumping system in a patient in Argentina and a second patient in the U.K.
The recall is an interim state, while the company investigates the source of the problem.