Endologix AFX2 Graft Risk Information Updated in FDA-Approved Labeling
The FDA is requiring new label warnings and post-marketing studies on the Endologix AFX2 graft system, which has been linked to potentially life-threatening endoleaks.
Tag Archives: Endoleak
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Endologix AFX Graft System Should Not Be Used For Abdominal Aortic Aneurysms Due To Endoleaks: FDA
The FDA is warning of potentially deadly endoleaks linked to endovascular graft systems, and call for patients with such systems to be closely monitored.
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Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and Fractures
The FDA has announced a Medtronic stent graft system recall after reports of malfunctions, serious injuries, and at least one death.
