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.
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, 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 abdomi
- Manufacturer
- Endologix
- Affected units
- 4,143
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Endologix
See all →- HighEndologix AFX Endovascular AAA System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- HighEndologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- HighEndologix AFX Endograft Recall for Type III Endoleak Surveillance
FDA (Devices) · 2018-10-10
- HighEndologix AFX Limb Extension Endograft Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- ModerateEndologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information
FDA (Devices) · 2017-01-25
Same hazard · documentation update
See all →- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips Mini Multi TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01