Recall Z-1049-2017 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I
| Date | Jan 19, 2017 (initiated Jan 4, 2017) |
| Status | Terminated |
| Reason | Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. |
| Root cause | Device Design |
| Action | Endologix sent a Dear Physician letter on 12/30/16 to inform them information related to the AFX Endovascular AAA System (AFX System). The letter provides updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Customers were informed of the voluntary recall of the small remaining quantity of original AFX with Strata graft material, and the larger diameter sizes of AFX2. Customers with any questions are instructed to contact their Endologix representative. Customers with questions were instructed to call their Endologix representative. |
| Quantity | 832 units |
| Distribution | Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.