The FDA has designated a recall of a Medtronic oxygenator used on kids as Class I, its most serious level.
The Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the venous reservoir supports and improves blood circulation during cardiopulmonary bypass.
According to an FDA notice, Medtronic is recalling the Affinity Pixie with Balance biosurface due to potentially elevated levels of harmful bacteria called endotoxins. Using the device with high levels of endotoxins could result in fever, infection, acute systemic toxic reaction or death, although there have been no complaints or reports of injuries or deaths related to the issue.
The recall affects devices distributed between April 29, 2020, and Nov. 20, 2020. Medtronic has recalled 126 devices since initiating the recall on Feb. 4, 2021, sending an urgent device recall notice to all affected customers, instructing them to identify and quarantine all unused affected products and return them all to the company.