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.
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 (endograft) with a specific hazard (Type III endoleaks) where injury has not yet been explicitly reported in the source text, fitting the 'High' criteria for risk-of-harm products.
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
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FDA (Devices) · 2017-01-25
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