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If your child or other loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a Medtronic Oxygenator Class Action Lawsuit and we can help. Please click the button below for a Free Confidential Case Evaluation or call us toll-free 24 hrs/day by dialing (866) 223-3784.

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What’s the Problem?

This FDA Recall began on March 24, 2021, and affects:

  • Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface — Model BBP241 — Lot 13340434
  • Perfusion Tubing Packs built with the affected Affinity Pixie CVR — Models BB10H89R4, HY10J00R6, HY11B40R1 — Lots 220265395, 220768819, 220911913

“Medtronic is recalling the specified device due to potentially elevated levels of harmful bacteria called endotoxins,” FDA said. “The use of a device with high endotoxin level may result in fever, infection, acute systemic toxic reaction, or death.”

The Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are used on newborns, infants and small pediatric patients who require a cardiopulmonary bypass procedure. The oxygenator works by adding oxygen to the blood and removing carbon dioxide. The venous reservoir improves blood circulation during the cardiopulmonary bypass.

Medtronic has issued an Urgent Medical Device Recall notification to all affected customers instructing them to quarantine all unused affected products and return them to the company. The recalled oxygenators were distributed from April 29, 2020 to November 20, 2020.

Do I Have a Medtronic Oxygenator Class Action Lawsuit?

The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic Oxygenator Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

If your child or other loved one has been injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 223-3784.