FDAFDA · Food and drugs·Recall number Z-1038-2017
AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Published January 25, 2017 · Recall initiated: December 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endologix
- Distributor
- US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
- Lot
- The correction is not lot specific. It applies to AFX procedures conducted after July 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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