Endologix recalls AFX2 Bifurcated Endograft Systems for potential Type III endoleaks requiring additional monitoring after December 2016.
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 AFX2 Bifurcated Endograft Systems for potential Type III endoleaks. This follow-up notice requires physicians to monitor patients more closely after the device is implanted.
Type III endoleaks are leaks of blood through the graft material that can cause complications if not detected. This recall follows updated surveillance recommendations to ensure timely intervention.
Physicians who have implanted the recalled AFX2 Bifurcated Endograft Systems since March 2011 are affected. Patients with these devices are at risk for endoleaks requiring additional monitoring.
The recalled devices have specific model numbers (BEA22-xx/Ixx-40, BEA25-xx/Ixx-40, BEA28-xx/Ixx-40) and were distributed from March 2011 to present. They are used in endovascular procedures for aneurysms.
Review the model number on your device to see if it matches the listed codes (e.g., BEA22-120/I20-40).
Reach out to your doctor for updated surveillance recommendations if you have the recalled device.
This is a follow-up notification to December 2016 updates about Type III endoleaks requiring enhanced patient monitoring.
No, the recall does not require stopping use. Physicians must follow updated monitoring protocols.
A Type III endoleak is a blood leak through the graft material that can cause complications if not detected early.
We’ve drafted a message you can send Endologix to request your refund or repair — edit it as you like.
Subject: Recall Z-0007-2019 — Endologix Endologix Hello, I own a Endologix that is covered by recall Z-0007-2019 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.
