Endologix recalls specific AFX/AFX2 endograft models due to potential Type III endoleaks requiring patient surveillance. This follow-up notification addresses updated monitoring 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/AFX2 endograft models used in aortic repair. The recall follows updated warnings about Type III endoleaks, which require additional patient monitoring to prevent complications.
Type III endoleaks can occur in these endografts, where blood flows through the graft's outer layer but not the inner layer. This may lead to complications if not monitored properly, but the recall focuses on updated surveillance rather than immediate danger.
Physicians who have implanted these specific endograft models in patients. Patients with these devices are at risk of endoleaks requiring additional monitoring.
Check if your device has model numbers like A22-22/C55, A25-25/C55, or A34-34/C80. These endografts were distributed from March 2011 through present. The recall applies to both infrarenal and suprarenal models.
Identify your device model number from the list provided in the recall notice.
Reach out to your doctor for updated surveillance recommendations as per the recall notice.
This is a follow-up notification to previous warnings about Type III endoleaks in these endografts, requiring updated patient surveillance.
No, the recall does not require stopping use. Patients should follow updated surveillance recommendations with their physician.
Affected models include infrarenal and suprarenal versions with specific model numbers like A22-22/C55, A25-25/C55, and A34-34/C80, distributed from March 2011 through present.
We’ve drafted a message you can send Endologix to request your refund or repair — edit it as you like.
Subject: Recall Z-0008-2019 — Endologix Endologix Hello, I own a Endologix that is covered by recall Z-0008-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
