Medtronic Bio-Console 560 Perfusion System Recall Class 1

FDA says a Medtronic 3/3 recall of 93 units of its Bio-Console 560 extracorporeal blood pumping console due to possible electrical failure causing the pump to stop is a Class 1 recall. An agency notice says the units were distributed between 4/1/09 and 2/12.

The Bio-Console 560 is used to pump and return blood to a person during cardiopulmonary bypass, FDA says. It can pump blood for up to six hours each time it is used.

The notice says other issues observed by users include the interface going blank, smoke coming from the device, and a burning odor during use. In cases in which the pump stopped or the interface went blank, users had to operate the pump using a hand crank until it restarted or could be replaced by a backup.

FDA says there have been nine complaints reported about the issue, including three injuries. No deaths have been reported.