Medtronic is recalling a blood pump that can stop during cardiopulmonary bypass surgery due to electrical failure.
The Bio-Console 560 extracorporeal blood pumping console is used to pump and return blood to a person during bypass, a procedure that temporarily takes over the function of the heart and lungs. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body.
In cases where the pump stopped, or the interface went blank, users had to operate the pump using a hand crank until the device restarted or could be replaced by a backup unit, according to the FDA. Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use, the agency said.
If the pump stops, patients could experience:
- Insufficient blood flow potentially leading to organ dysfunction.
- Blood clots potentially leading to low blood pressure.
- Reversible or irreversible neurological dysfunction.
Nine complaints have been reported about this device issue, including three injuries, the agency said. No deaths have been reported, but the FDA declared the recall Class I, its most serious recall classification.
Medtronic issued the recall on March 3, 2021, asking distributors and customers to identify potentially affected devices and use unaffected Bio-Console 560 devices, if available, until a company technician can repair the problem. Medtronic distributed the pumps from April 1, 2019, through Feb. 12, 2021.