- FDA categorized Abbott's recall of its CentriMag Acute Circulatory Support System as a Class I event, the agency announced Monday.
- Regulators put the recall of the devices in the highest risk category after finding pump and motor issues could cause injury or death. Abbott has recalled 381 devices in the U.S. and 283 outside the U.S.
- Abbott learned of 44 serious injuries and one death related to the product recall by the time it pulled the devices in August.
The CentriMag system is used to pump blood through a patient for up to six hours during open heart procedures, or to provide temporary blood circulatory support for up to 30 days in patients in cardiogenic shock after the heart's right side loses pumping power and blood backs up in the veins.
The system includes a console that controls the pump speed and flow. A cable connects the console to a motor, which allows flexibility in the pump motor and pump positioning. Electromagnetic interference can lead to calibration issues which may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms, the company said.
Abbott wrote to healthcare professionals in August warning that those calibration issues could lead to a range of patient complications, from stroke to severe organ damage to death.
The company recommended healthcare providers continue use of the motor until recalibration can be performed if it's not showing issues related to electromagnetic interference.
If electromagnetic interference occurs, which will be indicated by an alarm, the pump should be switched to the backup system described in the system's operating manual to mitigate the risks, the company said.
Other recommendations included moving the system away from the source of electromagnetic interference or removing the source of the interference and avoiding the use of power strips and socket extensions.
Abbott said it has made changes to the motor calibration process in manufacturing to mitigate the issue going forward. Representatives will contact customers to explain how affected motors can be recalibrated, the company said.
The recall is just the most recent one for Abbott related to heart devices and electronic issues. In June, the Abbott Park, Illinois-based company issued an urgent medical device recall letter to healthcare professionals about their Ellipse implantable cardioverter defibrillators (ICDs) over a latent defect in the electronics circuitry. In the Ellipse recall, the device’s damaged wires were the result of a faulty manufacturing process, FDA said.