The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- CentriMag Acute Circulatory Support System
- Lot numbers: L05333-0001 - L06608-0024
- Distribution Dates: November 22, 2017 - August 6, 2019
- Devices Recalled in the U.S.: 381
- Date Initiated by Firm: August 22, 2019
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).
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.
Reason for Recall
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-five (45) injuries and no deaths were reported at the time when Abbott initiated the recall in August 2019.
Who May be Affected
- Health care providers using the CentriMag System during open heart procedures
- All patients undergoing open heart procedures involving use of the CentriMag System
- Surgeons and perfusionistsusing the CentriMag System
- Hospital Bioengineering Departments using the CentriMag System
What to Do
On August 22, 2019, Abbott sent a Medical Device Recall letter to their customers with the following recommendations and actions:
Recommendations for Health Care Providers, Bioengineers, Patients and their Caregivers
- 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.
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.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX to 1-800-FDA-0178.