The U.S. Food and Drug Administration (FDA) announced on April 20 that Medtronic has issued a Class I recall of the Bio-Console 560 Extracorporeal Blood Pumping Console due to "reports of electrical failure causing the device to stop." This issue could lead to patients experiencing serious injury or death.

Specific risks associated with device usage include "insufficient blood flow potentially leading to organ dysfunction, blood clots potentially leading to low blood pressure, reversible or irreversible neurological dysfunction, or death." Users also have reported observing the interface going blank, smoke, and burning odor. The FDA has received nine complaints related to this device issue, including three injuries. No deaths have been reported.

Read the full recall and get the list of affected devices.

Keywords: ACC Advocacy, United States Food and Drug Administration

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