Endologix AFX Endograft Recall for Type III Endoleak Surveillance
Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (aortic endograft) where a specific hazard (Type III endoleak) has been observed, but the source text does not explicitly report injuries, deaths, or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Endologix is issuing a follow-up notification to physicians regarding the AFX/AFX2 Proximal (Aortic) Extension Endograft and related accessories. This update follows a previous notification sent in December 2016 and addresses the observation of Type III endoleaks associated with the device.
The recall covers 56,503 units distributed across the United States and multiple foreign countries. The affected products include various infrarenal and suprarenal models of the AFX Proximal Accessory and AFX Vela, with lots distributed from March 2011 to the present.
Physicians are advised to implement patient-tailored surveillance recommendations and general warnings or precautions for interventions to or through an existing AFX device. This action is intended to manage the risk associated with the observed endoleaks.
The recalled product
- Product
- ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A2
- Manufacturer
- Endologix
- Hazard
- Affected units
- 56,503
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots distributed from 03/2011 to present.
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 Limb Extension Endograft Recall for Type III Endoleaks
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- ModerateEndologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information
FDA (Devices) · 2017-01-25
- ModerateEndologix AFX 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