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FDA designates recall of circulatory support system as Class 1
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The FDA has designated Abbott’s product recall of a circulatory support system as a Class 1 recall, the most serious kind. The recall affects 381 devices distributed between Nov. 22, 2017 and Aug. 6, 2019.
Pump and motor issues have been linked with the circulatory support system (CentriMag Acute Circulatory Support System), used to pump blood through a patient during open heart procedures for up to 6 hours, and as temporary blood circulatory support for up to 30 days in those with cardiogenic shock. A calibration system error from electromagnetic interference may slow down or stop the pump, cause the console screen to go blank and lead to several inaccurate alarms, according to a MedWatch report from the FDA. These issues can put the patient at risk for service adverse health consequences such as severe organ damage, stroke or death.
Since the recall was initiated in August, there have been 44 injuries and one death reported to the company.
Abbott distributed a notice to customers on Aug. 22, alerting them that continued use of the system is acceptable until recalibration is performed, as long as there are no issues related to magnetic interference. The letter also instructed customers on what to do in the event of electromagnetic interference and how to avoid it, according to the report.
The company has changed the motor calibration process during manufacturing to mitigate the issue, according to the report, and customers will be contacted as to how affected motors can be calibrated.