Recall Z-1035-2017 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix
AFX Endovascular AAA System, Endoleak Type IIIA
| Date | Jan 18, 2017 (initiated Dec 27, 2016) |
| Status | Terminated |
| 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). |
| Root cause | Other |
| Action | Endologix sent an Dear Physician letter dated June 2, 2015, were sent to customers to inform them that Endologix has enclosed the 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 customer letter includes update on the clinical programs and commercial experience (ie. post-market surveillance). On January 2016, Dear Physician letters were sent to customers to inform them that Endologix has enclosed the 2015 Clinical Update c |
| Quantity | 40,967 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.