Endologix Updates Instructions for Use for AFX Endovascular AAA System
Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source describes a documentation update and system modification without reporting specific injuries, illnesses, or deaths. This aligns with the rubric for minor labeling/documentation issues or voluntary precautionary actions.
Plain-English summary
Endologix has updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System. This system is intended for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
The correction is not lot specific and applies to AFX procedures conducted after October 2015. The product was distributed in the United States and worldwide, including in Austria, Belgium, the Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, the Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
The recalled product
- Product
- AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
- Manufacturer
- Endologix
- Category
- Medical Device — Endovascular
- Hazard
Distribution
Distribution scope not specified by the agency.
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