The Food and Drug Administration (FDA) has announced a recall of specific models and lots of the Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface, as well as perfusion tubing packs containing them, due to potentially high levels of endotoxins.
The Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface are used for cardiopulmonary bypass in newborns, infants, and small pediatric patients. In cardiopulmonary bypass, devices are used to temporarily perform the function of the heart and lungs during the procedure. The oxygenator adds oxygen to the blood and removes carbon dioxide. The venous reservoir is used to support and improve blood circulation.
Medtronic is recalling the specified devices due to potentially elevated levels of harmful endotoxins. The use of a device with a high endotoxin level may result in fever, infection, acute systemic toxic reaction, or death.
The FDA has identified this as a Class I recall, the most serious type of recall, as use of the device may result in serious injury or death. There have been no complaints, reports of injuries, or deaths related to this device issue.
Food and Drug Administration (FDA). Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of Endotoxins [news release]. March 24, 2021. Available at: click here. Accessed March 25, 2021.