FDA Class I Recall: Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface for possible high levels of endotoxins
Medtronic is recalling the specified device due to potentially elevated levels of harmful bacteria called endotoxins, identified the U.S. Food and Drug Administration (FDA) in Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.
The use of a device with high endotoxin level may result in fever, infection, acute systemic toxic reaction, or death. There have been no complaints, reports of injuries, or deaths related to this device.
Recalled Product:
· Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface, Model BBP241
· Perfusion Tubing Packs built with the affected Affinity Pixie CVR, Models: BB10H89R4, HY10J00R6, HY11B40R1
· Distribution Dates: April 29, 2020 to November 20, 2020
The Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface are used in newborns, infants, and small pediatric patients requiring cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. The oxygenator adds oxygen to the blood and removes carbon dioxide. The venous reservoir is used to support and improve blood circulation during cardiopulmonary bypass.
