Endologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks
Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.
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 AFX2 Bifurcated Endograft System. This update provides patient-tailored surveillance recommendations and general warnings or precautions for interventions performed to or through an existing AFX device. The notification is a follow-up to a previous notice sent in December 2016.
The reason for this update is the observation of Type III endoleaks associated with the device. The source text does not specify the number of affected units, specific lot numbers, or reported injuries or illnesses.
Physicians are advised to review the provided surveillance recommendations and precautions when managing patients with this device. The source text does not provide specific instructions for consumers or patients beyond the notification to physicians.
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 →- SevereEndologix AFX Limb Extension Endograft Recall for Type III Endoleaks
FDA (Devices) · 2018-10-10
- SevereEndologix AFX Endograft Recall for Type III Endoleak Surveillance
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- SevereEndologix AFX Endovascular AAA System Recall for Type III Endoleaks
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Same hazard · endoleak
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- 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
Similar recalls
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- ModerateEndologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information
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- ModerateEndologix AFX Endovascular AAA System Instructions for Use Update
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- ModerateEndologix AFX Endovascular AAA System Recall for Updated Endoleak Information
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- ModerateEndologix AFX Endovascular AAA System Instructions for Use Updated
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