Medtronic Pulls Bio-Console 560 Blood Pumping Device from Market after Reports of Failures and Injuries
On March 26, 2021, the FDA announced that Medtronic Perfusion Systems is recalling its Bio-Console 560 Extracorporeal Blood Pumping Console after learning of several reports that device stopped pumping due to electrical failure during bypass surgery. Should the Bio-Console 600 stop working during surgery, the patient could suffer organ or neurological damage, blood clotting, or even death. Indeed, at least three injuries have already been reported.
Surgeons rely on Medtronic’s Bio-Console 560 to provide circulatory support during cardiopulmonary bypass for potentially up to six hours. Cardiopulmonary bypass requires a machine take over the function of the heart and lungs during a surgery. In particular, the Bio-Console 560 is used to pump and return blood to a patient whose heart and lungs are too weak to pump enough blood to the rest of the body. A failure of the device could have grave consequences.
Reasons for Medtronic’s Bio-Console 560 Recall
Unfortunately, Medtronic’s Bio-Console 560 has been reported to experience electrical failure, causing the device to stop pumping blood. According to the FDA’s recall notice, other issues observed during electrical failures include the console interface going blank, smoke coming from the console, and a burning odor during use. An electrical failure could result in serious physical harm or death. Accordingly, the FDA has labeled this a Class I recall, its most serious designation. This marks Medtronic’s fifth Class I recall since the beginning of February 2021.
If you or a loved one has suffered injuries you suspect were caused by a Medtronic Bio-Console 560 blood pumping device, contact one of Burg Simpson’s experienced product liability attorneys in Cincinnati today. Our award-winning medical device team has a proven history of results for thousands of clients nationwide, and possesses the knowledge and resources to investigate your potential claim. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today!