Recall Z-1039-2017 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 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
| 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 | Device Design |
| Action | Endologix sent a Dear Phycisicans Letter dated June 2, 2015, to all affected customers to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter informs the customers of the update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to inform the customers of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. Customers were informed the update reports the cumulative clinical d |
| Quantity | 4,143 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.