Endologix AFX Endovascular AAA System Instructions for Use Updated
Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 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 recall involves an FDA Class II classification with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
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 July 2015. The product was distributed nationwide in the United States and internationally to 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 should review the updated Instructions for Use and modifications to the AFX Endovascular AAA System. Patients who have had this procedure should consult their healthcare provider for specific guidance regarding the update.
The recalled product
- 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…
- Manufacturer
- Endologix
Distribution
Distributed nationwide across the United States.
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