Medtronic Recalls Devices Used For Infant Cardiopulmonary Bypass Surgery Due To Endotoxin Risks

Federal health officials have announced a recall for Medtronic oxygenators used to treat infants and young children undergoing cardiopulmonary bypass surgery, due to a risk certain devices may containing elevated levels of harmful bacteria called endotoxins.

A Medtronic Affinity Pixie oxygenator recall was posted by the FDA on March 24, indicating that the devices could introduce high levels of bacteria into the bloodstream of young, vulnerable patients, potentially resulting in the development of fever, infection, acute systemic toxic reaction, or could cause death.

The impacted devices are Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface, which are designed to add oxygen to the blood, and remove carbon dioxide while supporting blood circulation during cardiopulmonary bypass procedures in newborns, infants, and small pediatric patients.

Continued use of the devices poses a risk of severe adverse health consequences or death, leading the FDA to categorize the action as a Class I recall.

Endotoxins are usually gram-negative bacteria, which can cause toxicity in the human body. Examples include bacterial meningitis, and meningococcal disease; which causes sepsis and are extremely harmful to children and those with weakened immune systems or certain preexisting conditions.

The recall includes approximately 126 Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface with model number BBP241 and lot number 13340434, as well as Perfusion Tubing Packs built with the affected Affinity Pixie™ CVR with model numbers BB10H89R4, HY10J00R6, HY11B40R1 and lot numbers 220265395, 220768819, 220911913.

The devices were manufactured by Medtronic and distributed to healthcare facilities from April 29, 2020 through November 20, 2020

Medtronic released an Urgent Medical Device Recall Communication on February 4, instructing customers to quarantine all unused affected products and to contact Medtronic Customer Service 800-854-3570 to initiate a product return.

Since the initial announcement, the FDA has classified the recall as Class I, indicating it is the most serious of its kind and that the use of the product may cause serious and potentially life threatening adverse health consequences.