Endologix AFX Endovascular AAA System Instructions for Use Update
Endologix updated the Instructions for Use for the AFX Endovascular AAA System to address endoleak Type IIIB.
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 recall is classified as FDA Class II and involves an update to Instructions for Use and system modifications without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Endologix has issued a recall for the AFX Endovascular AAA System, a medical device intended for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is not lot-specific and applies to AFX procedures conducted after July 2015. The action was taken because Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX System. The distribution pattern includes the United States and worldwide locations, including Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Healthcare providers and patients should refer to the updated Instructions for Use and contact Endologix for further information regarding the modifications to the AFX Endovascular AAA System.
The recalled product
- Product
- 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
- Category
- Medical Device — Endovascular
- Affected units
- 40,967
Distribution
Distribution scope not specified by the agency.
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