What’s the Problem?
According to an FDA Recall Letter dated 3/24/21, this action 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 on Feb. 4, 2021, sent 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 in the U.S. between April 29, 2020 and November 20, 2020.
The Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are used on babies and small pediatric patients requiring cardiopulmonary bypass. The oxygenator adds oxygen to the blood and removes carbon dioxide. The venous reservoir is used to improve blood circulation during the bypass procedure.
This is an FDA Class I recall, the most serious type of recall. “Use of these devices may cause serious injuries or death,” the agency said.
Do I Have a Medtronic Oxygenator Lawsuit?
The Medical Device 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.