Device product
AFX Endovascular AAA System, Endoleak Type IIIA
Z-1035-2017
Product summary
- Firm
- Endologix
- Event
- Event 76075
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,967
- Official record key
device-enforcement:Z-1035-2017
Official wording
Reason: Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
Code information: The correction is not lot specific. It applies to AFX procedures conducted after June 2013
Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Derived failure modes
-
Unknown
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).