The US Food and Drug Administration (FDA) has designated the recall of Abbott’s CentriMag Acute Circulatory Support System as Class I or the most serious type.
Abbott’s device pumps blood through a patient for up to six hours during open-heart procedures. Furthermore, the CentriMag System offers temporary blood circulatory support for up to 30 days for patients in cardiogenic shock.
Abbott began a recall of the device in August over a calibration system error caused by electromagnetic interference that could cause the pump to slow or stop.
The interference may also cause the console screen to blank and result in inaccurate alarms.
The FDA added that slowing or stopping of the pump is associated with the risk of health complications including stroke, severe organ damage and even death.
When Abbott issued the recall in August, 44 injuries and one death due to the CentriMag System were reported. Of the total devices involved in the recall, 381 were in the US and 283 in other countries.
In its recall letter, the company recommended the use of the motor until recalibration can be performed if it is not showing electromagnetic interference issues.
In the case of electromagnetic interference, notified by alarm, the pump should be switched to the backup system, the company added.
Other recommendations were moving the system or console away from the electromagnetic interference sources and removing the source of the interference.
Abbott has since made changes to the motor calibration process in manufacturing to alleviate the problem.