Recall Z-1037-2017— Endologix
Class II · Terminated
Class II FDA medical device recall by Endologix, initiated 2016-12-27, terminated 2017-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: AFX Endovascular AAA System, Endoleak Type IIIA 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).. Reason: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System)..
- Recalling firm
- Endologix
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-27
- Terminated
- 2017-04-28
- Firm location
- Irvine, CA, United States
Product description
AFX Endovascular AAA System, Endoleak Type IIIA 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).
Reason for recall
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Data sourced from openFDA. This site is unofficial and independent of the FDA.