Endologix AFX Endovascular AAA System Recall for Type III Endoleaks
Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System 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 report specific injuries or fatalities, 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 Endovascular AAA System, a stent graft system used for medical interventions. This notice serves as an update to a previous notification sent in December 2016.
The recall is prompted by the observation of Type III endoleaks associated with the device. The notification provides patient-tailored surveillance recommendations and general warnings or precautions for any interventions performed to or through an existing AFX device.
Physicians are advised to review the specific surveillance recommendations and precautions included in the notification for patients who have received this device. The source text does not specify the number of affected units, specific lot numbers, or reported injuries.
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
See all →- 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
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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