Endologix AFX Endovascular AAA System Clinical Data Correction
Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.
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 correction to clinical data reports without mentioning specific physical hazards, injuries, or illnesses, fitting the criteria for a voluntary precautionary or documentation-related recall.
Plain-English summary
Endologix has initiated a correction to update reports containing cumulative clinical data and information for the AFX Endovascular AAA System and the Powerlink System. This recall is not lot-specific and applies to AFX procedures conducted after June 2013.
The affected products were distributed worldwide, including in the United States and various countries in Europe and the Middle East. The source text does not specify a particular hazard, injury, or illness associated with this correction.
Consumers and healthcare providers should refer to the official FDA recall notice for specific instructions on how to handle this data correction.
The recalled product
- Product
- AFX Endovascular AAA System, Endoleak Type IIIA
- Manufacturer
- Endologix
- Category
- Medical Device — Endovascular
- Hazard
- Affected units
- 40,967
Distribution
Distribution scope not specified by the agency.
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Similar recalls
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