USFDA issues Class 1 recall on Abbott’s blood pump

The US FDA classified the recall of Abbott Laboratories’ CentriMag blood pumping system as Class 1 or the most serious type of recall, following the death of a patient.

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 cardiogenic shock in 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 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.