Endologix AFX Endovascular AAA System Recall for Updated Endoleak Information
Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.
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 an FDA Class II recall initiated to update information on endoleak rates and surveillance, which fits the criteria for a moderate severity recall involving updated medical guidance rather than immediate physical harm.
Plain-English summary
Endologix is recalling 34 units of the AFX Endovascular AAA System. This medical device is intended for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). The recall was initiated because Endologix updated information on the rates of Type III endoleaks and provided suggestions for patient surveillance and treatment.
The affected units were distributed worldwide, including nationwide in the United States and internationally to countries such as Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland, Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand. Specific lot and serial numbers are listed in the agency's structured product information.
Healthcare providers and patients should refer to the updated information provided by Endologix regarding patient surveillance and treatment for Type III endoleaks. This recall is classified as Class II by the FDA.
The recalled product
- Product
- AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00
- Manufacturer
- Endologix
- Affected units
- 34
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 →- 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 · 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