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U.S. Department of Health and Human Services

Safety

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Ancure Endograft System and AneuRx Stent Graft System

Audience: Vascular Surgeons, Hospital operating room personnel

The FDA Center for Devices and Radiological Health (CDRH) has issued a public health notification regarding serious problems that have occurred with these two endovascular prosthetic graft devices, used to treat infrarenal Abdominal Aortic Aneurysm (AAA). The Notification letter provides a brief background on endovascular repair of AAA, lists the specific problems that occurred with the devices, and makes recommendations concerning their continued use. 

[April 30, 2001 - Public Health Notification - FDA]