Endologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information
Endologix is recalling the AFX2 Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.
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 indicates the action is based on updated information regarding surveillance and treatment rather than reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Endologix is recalling the AFX2 Endovascular AAA System, a medical device intended for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms. The recall involves 832 units of the device, which were distributed nationwide in the United States and internationally to various countries in Europe, the Middle East, South America, and Asia.
The reason for the recall is that Endologix has updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. This update allows healthcare providers to better manage patients who have received the device.
Healthcare providers and patients should review the updated information provided by Endologix regarding the monitoring and treatment of Type III endoleaks associated with the AFX2 Endovascular AAA System.
The recalled product
- Product
- AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16…
- Manufacturer
- Endologix
- Hazard
- Affected units
- 832
Distribution
Part of a larger recall action
This product is one of 2 recalled by Endologix under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Endologix
See all →- SevereEndologix AFX Limb Extension Endograft Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- SevereEndologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- SevereEndologix AFX Endograft Recall for Type III Endoleak Surveillance
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- SevereEndologix AFX Endovascular AAA System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- ModerateEndologix Updates Instructions for Use for AFX Endovascular AAA System
FDA (Devices) · 2017-01-25
Same hazard · endoleak
See all →- SevereMedtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects
FDA (Devices) · 2021-03-17
- HighMedtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability
FDA (Devices) · 2017-03-29
- ModerateEndologix AFX Endovascular AAA System Recall for Updated Endoleak Information
FDA (Devices) · 2017-01-25
Similar recalls
- ModerateEndologix AFX Endovascular AAA System Instructions for Use Update
FDA (Devices) · 2017-01-25
- SevereEndologix AFX Endovascular AAA System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- ModerateEndologix Updates Instructions for Use for AFX Endovascular AAA System
FDA (Devices) · 2017-01-25
- SevereEndologix AFX Endograft Recall for Type III Endoleak Surveillance
FDA (Devices) · 2018-10-10
- SevereEndologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- ModerateEndologix AFX Endovascular AAA System Clinical Data Correction
FDA (Devices) · 2017-01-25