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Medtronic Bio-Console 560 Blood Pumping Console Recall

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 […]

Medtronic Perfusion Systems’ Extracorporeal Blood Pumping Console Medtronic Bio-Console 560 Recalled

Medtronic bio-console 560 blood pumping console recall

Medtronic Bio-Console 560 Recall

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.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

Did you lose a loved one due to a defective Medtronic Bio-Console 560?  Parker Waichman LLP helps victims and families receive justice and full monetary compensation for harm caused by a Medtronic Bio-Console 560 defect. Trust your case with our product liability lawsuit attorneys. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).

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