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Medtronic’s Perfusion System Recall Is Fifth Class I In 2 Months

 
• By Elizabeth Orr

The Bio-Console 560 extracorporeal blood pumping console is being recalled over reports it could lose power during bypass surgery, which could lead to organ or neural dysfunction, blood clots, or even death.

detailed illustration of a compass with Recall text, eps10 vector

The US Food and Drug Administration announced a high-risk class I recall of Medtronic Perfusion’s Bio-Console 560 extracorporeal blood pumping console on 20 April, marking the fifth recall of a Medtronic product since 1 March.

Medtronic is voluntarily recalling the device, which temporarily circulates blood during cardiopulmonary bypass surgery, following reports it could stop suddenly...

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