Endologix recalls specific AFX Endovascular AAA stent graft systems due to potential Type III endoleaks requiring additional monitoring. Patients should follow updated surveillance recommendations.
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 out in December 2016. The updates are related to the observation of Type III endoleaks.
Endologix is recalling certain AFX Endovascular AAA stent graft systems for follow-up monitoring due to potential Type III endoleaks. This recall is a follow-up to previous warnings and does not require immediate action but requires updated surveillance.
Type III endoleaks are leaks in the blood vessel that can cause complications if not monitored. Endologix is updating surveillance recommendations to ensure timely detection and management of these leaks.
Physicians who have implanted the recalled AFX Endovascular AAA stent graft systems since March 2011 are affected. Patients with these devices are at risk of endoleaks requiring additional monitoring.
Check if your device has a model reference code from the list provided (e.g., BA22-120/I20-40) and was implanted between March 2011 and present.
Endologix has updated patient surveillance guidelines for Type III endoleaks. Follow these recommendations with your healthcare provider.
No, this recall does not require stopping use. Endologix is providing updated surveillance recommendations for monitoring.
A Type III endoleak is a leak in the blood vessel that can cause complications if not monitored. Endologix is updating surveillance to manage these risks.
Check if your device has a model reference code from the list (e.g., BA22-120/I20-40) and was implanted between March 2011 and present.
We’ve drafted a message you can send Endologix to request your refund or repair — edit it as you like.
Subject: Recall Z-0006-2019 — Endologix Endologix Hello, I own a Endologix that is covered by recall Z-0006-2019 from Endologix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
