FDA: Class I Recall for CentriMag Circulatory Support System Motor

Electromagnetic interference may cause a calibration problem that affects the pump and console, the agency says.

FDA: Class I Recall for CentriMag Circulatory Support System Motor

The US Food and Drug Administration has designated Abbott’s recent recall of the CentriMag circulatory support system motor as Class I, the most serious type. The manufacturer initiated the recall on August 22, 2019, at which point there had been 45 injuries but no deaths reported due to the problem.

“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,” the FDA noted in an announcement earlier this week. “If the pump slows or stops, the patient is at risk of serious adverse health consequences such as stroke, severe organ damage, or death.”

CentriMag, when used during open-heart procedures, can pump blood through a patient for as long as 6 hours. It also can provide circulatory support for up to 30 days in a patient with cardiogenic shock due to acute right ventricular failure. The system consists of a console to control pump speed and flow as well as a cable-connected motor.

“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,” the FDA said.

Prior to recalibration, CentriMag may be used unless there are signs of electromagnetic interference, the company advised in a letter to customers including both healthcare providers and bioengineers. If a problem arises, alarms will sound and users should switch the pump to the backup system.

Abbott also pointed out that sources of electromagnetic interference near CentriMag may affect the console’s performance. Beyond removing this equipment or moving the CentriMag system, the manufacturer also emphasized that it should be plugged into AC wall outlets rather into power strips or socket extensions.

A total of 381 devices have been recalled in the United States and 283 in other countries, the FDA reports. The recall affects lot numbers L05333-0001 to L06608-0024, which were distributed between November 22, 2017, and August 6, 2019. Additional details on the model, lot numbers, advice to users, and event reporting procedures are available online.

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