Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms. If the pump slows or stops, the patient is at risk of service adverse health consequences such as stroke, severe organ damage or death.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Forty-four injuries and one death were reported at the time when Abbott initiated the recall in August 2019.
The CentriMag System is intended to pump blood through a patient for up to six hours during open heart procedures. The system also provides temporary blood circulatory support for up to 30 days for patients in cardiac shock when the right side of the heart loses pumping power, and blood backs up in the body's veins (acute right ventricular failure).
The system includes a console that controls the pump speed and flow. A cable connects the console to a motor, allowing flexibility in the pump motor and pump positioning.
Abbott has implemented changes to the motor calibration process in manufacturing to mitigate the issue. An Abbott representative will contact their customers to explain how affected motors can be recalibrated.
