November 4, 2019 — Abbott is recalling its CentriMag Acute Circulatory Support System due to a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop, the console screen to go 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) said there have been 44 injuries and one death reported at the time when Abbott initiated the recall in late August 2019. The FDA had listed this as a Class I recall. The recall includes lot numbers L05333-0001 through L06608-0024 and includes 381 systems in the United States.
The CentriMag 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 when the right side of the heart loses pumping power, and blood backs up in the body's veins due to 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.
On Aug. 22, 2019, Abbott sent a medical device recall letter to its customers with the following recommendations and actions:
• Continued use of the motor is acceptable until recalibration can be performed, as long as the motor does not exhibit the issues related to electromagnetic interference.
• In the event of an electromagnetic interference issue, alarms will alert caregivers of the problem.
• Should an electromagnetic interference issue occur, switch the pump to the backup system as described in the CentriMag System Operating Manual.
• Electromagnetic interference sources in the area of the system may interfere with console's performance. If changes occur in the operating area of the console due to electromagnetic interference sources, immediately remove the source of electromagnetic interference or move the console away from the source of the electromagnetic interference.
• The second-generation CentriMag Primary Console may interfere with the operation of other equipment in close proximity.
• Do not place equipment, other than an additional second-generation primary CentriMag console, near the main console or motor.
• Insert the cord into the AC wall outlet only. Do not use power strips and socket extensions. In the bi-ventricular (BVAD) configuration, both console power cords must be inserted directly into an AC wall outlet.
• All customers should complete the acknowledgement form included in the letter and return it to Abbott.
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.
Customers with questions can contact their Abbott MCS Clinical Specialist or MCS HeartLine 1-800-456-1477, 24 hours a day, 7 days a week.