Medtronic Perfusion Systems’ Extracorporeal Blood Pumping Console Medtronic Bio-Console 560 Recalled
WASHINGTON, DC – The US Food and Drug Administration announced the Class I recall of Medtronic Perfusion Systems’ extracorporeal blood pumping console. Class I recalls are the most severe type of recall issued by the FDA and identifies a product as having the potential to cause injury or death. According to the FDA’s press release, Medtronic recalled its Bio-Console 560 blood pumping console because of a defect that could cause an electrical failure that stops the pump causing serious injury or death.
According to the FDA’s press release, several other issues are reported with the medical device, including a burning odor during use, the interface becoming blank, and smoke emanating from the device. When a Medtronic blood pump stopped or when the interface screen went blank, users worked “the pump by using a hand crank until the device restarted or replaced with a backup unit.”
The Medtronic Bio-Console 560 blood pumping console is utilized to pump and return blood to a patient during cardiopulmonary bypass. The unit is able to pump the blood for up to six hours per time used.
The FDA states that there have been nine reported complaints about the recalled device. The recall includes 93 Medtronic Bio-Console 560 blood pumping consoles sold between April 1, 2019 and Feb. 21, 2021.
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