Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface Recall
WASHINGTON, DC – The US Food and Drug Administration has announced the recall of Medtronic’s Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface due to possible high levels of endotoxins. The FDA has classified the recall as a Class I recall, which is the most severe type of recall. Class I recalls identify a recall of a product that may cause injury or death.
Medtronic initiated the recall because the device may have elevated levels of harmful bacteria called endotoxins. Endotoxin exposure can lead to death or severe medical conditions such fever, acute systemic toxic reaction, or infection.
The Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface are used on small pediatric patients, infants, and newborns who requiring a cardiopulmonary bypass. Cardiopulmonary bypass is a surgical procedure that temporarily takes over the function of the lungs and heart of the patient during surgery. The oxygenator removes carbon dioxide and adds oxygen to the blood. The venous reservoir improves and supports blood circulation during cardiopulmonary bypass.
The Affinity Pixie™ Oxygenator and Cardiotomy-Venous Reservoir with Balance™ Biosurface recalled have model numbers BBP241, BB10H89R4, HY10J00R6, HY11B40R1 and are from lots 13340434, 220265395, 220768819, and 220911913. The devices were distribution from April 29, 2020 to November 20, 2020.
Health care providers are asked to stop using the affected Medtronic device and to contact Medtronic Customer Service to send back the unit for a full refund. Also, consumers health care professionals are asked to report all adverse reactions or quality issues to MedWatch.
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