Endologix AFX Endovascular AAA System Instructions for Use Update
Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.
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, but the source text describes a documentation update (IFU) and modifications without reporting any specific injuries, illnesses, or structural defects, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Endologix has initiated a recall for the AFX Endovascular AAA System, a medical device intended for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms. The recall involves 4,143 devices that were distributed nationwide in the United States and internationally to multiple countries in Europe and the Middle East.
The reason for this recall is that Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX System. The source text does not specify a particular defect, injury, or illness associated with these updates.
Healthcare providers and patients who have received the AFX Endovascular AAA System should consult the updated Instructions for Use and contact Endologix for further information regarding the implemented modifications.
The recalled product
- Product
- AFX Endovascular AAA System, Endoleak Type: IIIB 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…
- Manufacturer
- Endologix
- Affected units
- 4,143
Distribution
Distributed nationwide across the United States.
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Similar recalls
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