Medtronic Recalls Bio-Console 560 for Electrical Failure and Pump Stop

Learn more about Medtronic's Recall of Bio-Console 560

If your email program has trouble displaying this email, view as a webpage. Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop. Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use. If the pump stops, patients could experience insufficient blood flow potentially leading to organ dysfunction, blood clots potentially leading to low blood pressure, reversible or irreversible neurological dysfunction, or death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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