Endologix AFX Limb Extension Endograft Recall for Type III Endoleaks
Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension 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 medical device with a reported defect (Type III endoleaks) that poses a risk of harm, but the source text does not explicitly report injuries or deaths, fitting the 'High' severity 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 Limb (Iliac) Extension Endograft. This notice provides patient-tailored surveillance recommendations and general warnings or precautions for interventions performed to or through an existing AFX device.
The recall is related to the observation of Type III endoleaks. This notification serves as an update to a previous notice sent in December 2016.
The affected products include various models of the AFX Limb Accessory and AFX Stand Alone endografts. The distribution pattern includes the United States and numerous foreign countries. The recalling firm is Endologix.
The recalled product
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
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- HighEndologix AFX Endograft Recall for Type III Endoleak Surveillance
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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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