Recall Z-1054-2017 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
| Date | Jan 19, 2017 (initiated Dec 27, 2016) |
| Status | Terminated |
| Reason | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). |
| Root cause | Under Investigation by firm |
| Action | A Dear Physician letter dated 6/2/15 was sent to customers to inform them of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update on the clinical programs and commercial experience (i.e., post-market surveillance). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports for the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX |
| Quantity | 17,139 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.