Endologix recalls Ovation iX Abdominal Stent Graft Systems with specific reference numbers due to potential polymer leaks during implantation, which could cause systemic issues or aneurysms.
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
Endologix is recalling certain Ovation iX Abdominal Stent Graft Systems because a material weakness near the polymer channel might leak during implantation. This could lead to serious complications like aneurysms or systemic issues if the leak occurs.
A material weakness near the polymer fill channel could become compromised when pressurized with liquid polymer. This might cause polymer leaks during implantation, potentially leading to systemic issues or aneurysms.
Patients who have not yet implanted the device are affected. Those with the specific reference numbers listed in the recall are most at risk.
Check for reference numbers TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, or TV-AB3480-J. The device is only for patients who have not yet had the implant.
Identify if your device has the reference numbers TV-AB2080-I through TV-AB3480-J.
The recalled devices are Ovation iX Abdominal Stent Graft Systems with reference numbers TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, or TV-AB3480-J.
A material weakness near the polymer fill channel may become compromised during pressurization with liquid polymer, potentially causing polymer leaks during implantation that could lead to systemic issues or aneurysms.
The recall applies only to devices not yet implanted. If you have not had the implant, you should check the reference numbers and contact your healthcare provider.
We’ve drafted a message you can send Endologix to request your refund or repair — edit it as you like.
Subject: Recall Z-2263-2020 — Endologix Endologix Hello, I own a Endologix that is covered by recall Z-2263-2020 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.
