FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface

Editor's Note

The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious.

The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device with high endotoxin levels my result in fever, infection, acute systemic toxic reaction, or death.

Those affected include healthcare workers who handle the device and surgical patients who undergo procedures using the device, which is used during cardiopulmonary bypass procedures in newborns, infants, and small pediatric patients.

Distribution dates were April 29, 2020 to November 20, 2020. To date, there have been no complaints, reports of injuries, or deaths related to this device.