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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent…"
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…
- 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 →- 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
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- SevereEndologix AFX Endovascular AAA System Recall for Type III Endoleaks
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- ModerateEndologix AFX Endovascular AAA System Clinical Data Correction
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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
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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
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- ModerateEndologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information
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- ModerateEndologix Updates Instructions for Use for AFX Endovascular AAA System
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- ModerateEndologix AFX Endovascular AAA System Instructions for Use Update
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- ModerateEndologix AFX Endovascular AAA System Clinical Data Correction
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