Medtronic recalled the Affinity Pixie Oxygenators due to a risk of bacteria contamination that could cause deadly infections in children undergoing heart surgery.
Need a Texas Medtronic Affinity Pixie Oxygenator Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If your child or a loved one was diagnosed with an infection or another severe side effect of the Medtronic Affinity Pixie Oxygenator, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Medtronic Affinity Pixie™ Oxygenator Recall
February 4, 2021 — Medtronic has recalled 126 medical devices that are used to oxygenate the blood of young children undergoing cardiopulmonary bypass surgery.
What is the Problem?
The recall involves the Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface. These devices may be contaminated with high levels of endotoxins, which are bacteria that can cause severe, life-threatening side effects, such as:
- Acute systemic toxic reactions
What is the Medtronic Affinity Pixie Oxygenator?
The Medtronic Affinity Pixie Oxygenator is a device that takes over the function of the heart and lungs during cardiopulmonary bypass surgery involving newborns, infants, and small pediatric patients. The machine is adds oxygen to the blood, removes carbon dioxide, and supports the circulation of blood to the body during the surgery.
What Devices Were Recalled?
Medtronic recalled the Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance™ Biosurface, with Model BBP241 and Lot 13340434. The recall includes about 126 devices that were distributed from April 29, 2020 to November 20, 2020.
Class 1 Recall for Medtronic Oxygenator
The Medtronic oxygenator recall has been designated as a Class 1 recall, which is the most serious type of recall. The FDA recall warns: “Use of these devices may cause serious injuries or death.”
Need a Medtronic Affinity Pixie Oxygenator Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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