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.

• Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and Fractures

  April 12, 2021

  Russell Maas

  The FDA has announced a Medtronic stent graft system recall after reports of malfunctions, serious injuries, and at least one death.