Endologix Updates Instructions for Use for AFX Endovascular AAA System
Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.
What this means for you
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes the action as an update to the Instructions for Use and implementation of modifications, without reporting specific injuries or deaths, aligning with a Moderate severity rating for a precautionary or corrective device update.
Plain-English summary
Endologix has initiated a recall of 17,139 units of the AFX Endovascular AAA System, also known as AFX Bifurcated and Accessory Stent Grafts. The recall is being conducted to update the Instructions for Use (IFU) and to implement modifications to the device.
The affected units were 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 recall covers specific lot codes manufactured between July 2015 and November 2016.
This action is classified as an FDA Class II recall. Healthcare providers and patients should refer to the updated Instructions for Use and contact Endologix for details regarding the device 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
- Manufacturer
- Endologix
- Affected units
- 17,139
Distribution
Distribution scope not specified by the agency.
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