> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Endologix Recalls Ovation iX Abdominal Stent Graft
- URL: https://www.fdaweb.com/endologix-recalls-ovation-ix-abdominal-stent-graft/
- Published: 2020-06-16T12:00:00.000Z
- Updated: 2026-09-14T16:18:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147020

Endologix has recalled the Ovation iX Abdominal Stent Graft System due to risks of liquid polymer leaks during implantation. In 2018, the company issued an [important safety update](https://endologix.com/wp-content/uploads/2018/08/Ovation-FSN-Aug-06-Final.pdf?ref=fdaweb.com) about the leaks which it then said were due to incorrect use of the device. Now, the recall is clarifying that the root cause for most polymer leaks is a material weakness caused during the manufacturing process.

“The weakened area may gap or open during use, which can cause liquid polymer to leak outside of the device as it is filled,” an FDA [recall notice](https://www.fda.gov/medical-devices/endologix-inc-recalls-ovation-ix-abdominal-stent-graft-systems-due-risks-polymer-leaks-during?utm%5Fcampaign=Ovation%20iX%20Abdominal%20Stent%20Graft%20By%20Endologix&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. “If there is not enough liquid polymer in the device to seal the aneurysm, blood may continue to flow into the aneurysm, requiring additional procedures to properly seal off the aneurysm. Liquid polymer may leak into the patient’s body. This may cause serious health consequences, including severe allergic type reactions, unstable blood pressure, tissue damage ([necrosis](https://medlineplus.gov/ency/article/002266.htm?ref=fdaweb.com)), organ failure, cardiac arrest, central nervous system problems, and death.”

The device is intended to treat patients with an abdominal aortic or aortoiliac aneurysm, a condition that occurs when the body’s largest blood vessel (the aorta) becomes stretched and thin, causing the vessel to bulge or expand. Physicians use stent grafts to repair aneurysms and reduce the risk of rupture.