The FDA has announced a Class 1 recall for the Medtronic Affinity Pixie Oxygenator with Balance™ Biosurface, which is used on infants and children undergoing heart bypass surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Medtronic Affinity Pixie™ Oxygenator induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Medtronic Recalls Affinity Pixie™ Oxygenator
On February 4, 2021, Medtronic recalled 126 oxygenator machines for infants undergoing bypass surgery due to a risk of endotoxins that could cause fever, infection, acute systemic toxic reactions, or death.
What is the Affinity Pixie Oxygenator?
The recall involves the Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface. These machines are used during cardiopulmonary bypass surgery in newborns, infants, and small pediatric patients. The machine temporarily takes over the function of the heart and lungs during open-heart surgery, adding oxygen to the blood, removing carbon dioxide, and circulating blood.
What is the Problem?
Medtronic recalled the Affinity Pixie Oxygenator due to a risk of high levels of endotoxins. Endotoxins are bacteria that can cause severe side effects, such as:
- Fever
- Infection
- Acute systemic toxic reaction
- Death
What Oxygenators Were Recalled?
The recall includes the Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface — Model BBP241 and Lot: 13340434. The recalled devices were distributed between April 29, 2020 and November 20, 2020. No injuries were reported.
FDA Issues Class 1 Recall for Medtronic Oxygenator
The FDA has designated this as a Class 1 recall, which is the most serious type of recall the government can issue. “Use of these devices may cause serious injuries or death,” according to the FDA warning.
Do I have a Medtronic Affinity Pixie Oxygenator Lawsuit?
The Schmidt Firm, PLLC is currently accepting Medtronic Affinity Pixie™ Oxygenator induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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