Endologix recalls specific AFX/AFX2 endograft models due to potential Type III endoleaks requiring enhanced patient surveillance. This follow-up notice addresses updated warnings for interventions involving these devices.
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/AFX2 endograft models used in vascular procedures because they may cause Type III endoleaks. This requires doctors to monitor patients more closely after implantation to prevent complications.
Type III endoleaks occur when blood flows through a gap in the endograft, potentially causing the device to fail. This can lead to complications like bleeding or organ damage if not properly monitored.
Physicians who have implanted the recalled endografts are affected. Patients with these devices are at risk of complications if they require future procedures.
Check if your device model matches the listed numbers (e.g., I16-16/C55, I20-13/C70F) and was implanted between March 2011 and present.
Check the model number on your endograft device to see if it matches the recalled list (e.g., I16-16/C55, I20-13/C70F).
Contact your doctor to discuss updated surveillance recommendations for patients with this device.
This is a follow-up notification to address observed Type III endoleaks in the AFX/AFX2 endografts, requiring enhanced patient monitoring.
No, but your doctor may need to monitor you more closely for potential complications.
The affected models include I16-16/C55, I20-13/C70F, I16-16/C55F, I20-13/C88F, and others listed in the recall notice.
We’ve drafted a message you can send Endologix to request your refund or repair — edit it as you like.
Subject: Recall Z-0009-2019 — Endologix Endologix Hello, I own a Endologix that is covered by recall Z-0009-2019 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.
