A recall has been issued for Medtronic Bio-Console 560 blood pumping consoles, following reports of electrical failures which caused the devices to stop working, placing patient lives at risk.
The FDA announced the Medtronic Bio-Console 560 recall on April 20, indicating there have been at least nine reports of the devices failing. While no deaths have been linked to the blood pump problems, at least three injuries have been reported.
The Medtronic blood pump is used during cardiopulmonary bypass, temporarily pumping and returning blood to for the heart and lungs. The cardiopulmonary bypass procedure aids in breathing support and circulating blood for a person who had weak lungs and heart.
According to the FDA, electrical failures can cause the device to stop pumping. In addition, users have reported the interface going blank, the devices beginning to smoke, and reports they began to emit a burning odor. When the pumps have stopped or the screens have blanked out, users had to turn a hand crank until the devices restarted or could be replaced.
The agency warns that blood pump failures can result in insufficient flow, which could cause organ dysfunction, as well as blood clots which can cause low blood pressure, and reversible or irreversible neurological dysfunction. The FDA also warns the problem could lead to patient deaths.
The recall affects the Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, with model numbers 560BC, 560BCS, 560BC1, 560BCS1, and R560BCS1. The devices were distributed between April 1, 2019 and February 12, 2021 and includes 93 devices sold nationwide.
Medtronic first sent out an Urgent Medical Device Correction letter to affected distributors and customers on March 3. The FDA’s most recent action declared that letter to be a Class I medical device recall; the most serious recall classification, indicating the agency believes the problem could lead to severe injuries or deaths.
The manufacturer urged its customers to review the letter to identify potentially affected devices and use unaffected Bio-Console 560 devices until it can correct the problem in the affected consoles. The manufacturer has also asked customers to complete a Customer Confirmation Certificate which was included with the letter and scan or email that certificate to RS.CFQFCA@medtronic.com. Customers can contact a Medtronic Field Service Representative to schedule the service event.