Most Serious: USFDA issues Class 1 recall on Abbotts CentriMag blood pumping system
The U.S. Food and Drug Administration on Monday classified the recall of Abbott Laboratories' CentriMag blood pumping system following the death of a patient, as Class 1 or the most serious type of recall.
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.
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.
Abbott said it had issued a letter in August to inform hospitals about the potential electromagnetic interference disrupting device operation.
"All impacted CentriMag consoles were replaced," the company told Reuters.
The FDA uses the term "recall" when a manufacturer takes corrective action or removes a problematic medical device from the market. A recall does not always mean that customers must stop using the product or return it to the company.
To check out more details about the recall, please visit the following link