FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console

Editor's Note

The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass.

The recall was initiated because of reports of electrical failure causing the device to stop. Other issues include the interface going blank, smoke coming from the device, and a burning odor during use.

There have been nine complaints, including three injuries. No deaths have been reported.

Distribution dates were April 1, 2019 to February 12, 2021.