Devices

Device Recall AFX Endovascular AAA System, Endoleak Type IIIB

Model / Serial
The correction is not lot specific. It applies to AFX procedures conducted after July 2015
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
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.
Product Description
AFX Endovascular AAA System, Endoleak Type IIIB; || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Manufacturer
Endologix
1 Event
- Recall of Device Recall AFX Endovascular AAA System, Endoleak Type IIIB

Manufacturer

Endologix

Manufacturer Address
Endologix, 35 Hammond, Irvine CA 92618-1607
Manufacturer Parent Company (2017)
Endologix Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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