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# Endologix Ovation iX Correction Notice Class 1
- URL: https://www.fdaweb.com/endologix-ovation-ix-correction-notice-class-1/
- Published: 2020-07-15T12:00:00.000Z
- Updated: 2026-09-14T16:21:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147200

FDA says that Endologix has issued a correction notice for its Ovation iX system that identifies the root cause of polymer leaks. FDA has classified the action as a Class 1 recall. An agency [notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endologix-issues-correction-notice-ovation-ix-abdominal-stent-graft-system?utm%5Fcampaign=Endologix%20Issues%20Correction%20Notice%20for%20Ovation%20iX%20Abdominal%20Stent%20Graft%20System&utm%5Fmedium=email&utm%5Fsource=Eloqua#recall-announcement) says that no physical removal of the product is planned or needed.

The agency says the correction notice informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related, it says.

In addition to new information on the root cause of leaks, FDA says, the company notice also has information on the incidence of aneurysm-related complications and the lack of long-term sequelae following the underfilling of the polymer rings caused by a leak.