AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Recall
- Recall Number
- Z-1037-2017
- Event Number
- 76086
- FEI Number
- 3011063223
- Product Code
- MIH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 27, 2016
- Posted
- January 18, 2017
- Terminated
- April 28, 2017
- Address
- Endologix 35, Hammond Irvine, CA, 92618-1607
Description
AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Endologix sent a dear physician letter dated June 2, 2015, to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). The letter informs the Physicians of the year's update on the clinical programs and commercial experience (i.e. post-market surveillance). A dear physician letter dated January 2016 was seen to inform them of the enclosed 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (i.e. post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. A dear physician letter dated December 27, 2016, will be sent to provide important information related to the AFX Endovascular AAA System (AFX System). Endologix is informing the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product. Customers with any questions are instructed to contact their local Endologix representative.
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.