3 results

• Endologix AFX2 Graft Risk Information Updated in FDA-Approved Labeling

  December 8, 2022

  Russell Maas

  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.

• Endologix AFX Graft System Should Not Be Used For Abdominal Aortic Aneurysms Due To Endoleaks: FDA

  January 17, 2022

  Russell Maas

  The FDA is warning of potentially deadly endoleaks linked to endovascular graft systems, and call for patients with such systems to be closely monitored.

• Some Endovascular Graft Systems Used For Aortic Aneurysms May Leak, FDA Warns

  September 29, 2017

  Russell Maas

  The FDA is warning of potential leaks in endovascular graft systems that could cause complications following aortic aneurysm repair surgery.