What’s the Problem?
This FDA Recall began on Feb. 21, 2021, and affects all unused Medtronic Valiant Navion thoracic stent graft systems.
Medtronic issued the recall after 3 patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, 2 of which had type IIIb endoleaks, and 1 patient who died. A subsequent analysis found that 7 of 87 patients had stent ring enlargement beyond the design specification.
Medtronic is conducting an investigation into this issue, and is continuing to work with the FDA and other regulatory authorities around the world to solve the problem.
Patients with a Medtronic Valiant Navion thoracic stent graft system should contact their healthcare provider with any questions, FDA said.
Do I Have a Medtronic Stent 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 Stent Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled stent, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.