On October 30, 2019, the U.S. Food and Drug Administration (FDA) announced that Abbott initiated a recall of its CentriMag circulatory support system. According to the recall notice, the system consists of several components (a pump, motor, and console/screen) intended to work together to pump blood through a patient during open heart procedures. The system can also be used to provide temporary blood circulatory support for patients in cardiogenic shock. However, the systems have been found to be susceptible to electromagnetic interference which can cause the pump to slow or even stop. The pump slowing or stopping can lead to blood circulation issues, such as a deficient supply of oxygen being transported to the patient’s brain. This puts the patient at risk of serious injuries, including a stroke, severe organ damage, or even death. Because of the severity of the injuries involved, FDA has classified the recall of the surgical pump as Class I, its most critical designation. Indeed, Abbott had already received reports of 44 injuries and one death associated with its system.
If you or a loved one have suffered complications during an open-heart surgery or while in cardiogenic shock, call the experienced medical device attorneys at Burg Simpson’s Cincinnati office today. Our award-winning product liability lawyers have spent years holding drug and medical device manufacturers accountable for their wrongdoing. Call 513-852-5600 or fill out our contact form for a free, no-obligation consultation today.