The FDA has announced that Medtronic is recalling its Bio-Console 560 Extracorporeal Blood Pumping Console due to multiple reports of electrical failure.
This is a Class I recall, which means using the affected products “may cause serious injuries or death.”
The electrical failure may cause the device to give off a burning odor, smoke or stop working altogether. If the pump does stop working, patients are at a risk of insufficient blood flow, blood clots, neurological dysfunction or even death. A total of nine issues have been reported so far, including three injuries and no deaths.
Medtronic officially initiated the recall on March 3, sending a letter to all distributors and customers who may have been affected. If a device has not been impacted by these issues, users were instructed to continue use “until correction has been completed.”
According to the FDA, this recall includes models 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1. All products were distributed from April 2019 to February 2021.
Click here to read more details on the FDA website.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.