A MedWatch Safety Alert was just added to the FDA Medical Device Recalls webpage. 

TOPIC: CentriMag Circulatory Support System Motor by Abbott: Class I Recall - Due to Pump and Motor Issues

AUDIENCE: Cardiology, Health Professional, Risk Manager

BACKGROUND: 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 when the right side of the heart loses pumping power and blood backs up in the body's veins (acute right ventricular failure).

ISSUE: 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.

Forty-four (44) injuries and one (1) death were reported at the time when Abbott initiated the recall in August 2019.

The affected lot numbers are L05333-0001 - L06608-0024.

RECOMMENDATION:

• 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 2nd Generation CentriMag Primary Console may interfere with the operation of other equipment in close proximity.
• Do not place equipment, other than an additional 2nd 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 BVAD configuration both console power cords must be inserted directly into an AC wall outlet.

Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.

Download form or click this link to call to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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