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# Endologix Restricts Nellix Stent Graft
- URL: https://www.fdaweb.com/endologix-restricts-nellix-stent-graft/
- Published: 2019-01-04T12:00:00.000Z
- Updated: 2026-09-15T00:52:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143089

Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. The company is recalling all existing inventory data, and use under the protocol will first be pre-screened by a panel of doctors and supported by the company’s clinical specialists, Endologix says. The recall and limited use order is based on concerns raised in publications about suboptimal outcomes when the device is used outside current instructions for use, it adds.

“Ensuring patient safety and optimal clinical outcomes is our top priority, and the current level of off-label use of the Nellix system cannot continue if we are to protect and preserve the potential for transformative endovascular aneurysm sealing therapy,” Endologix says. “Taking these actions aligns with clinical practice standards, allows us to control off-label use and will help us ensure appropriate application of the therapy.”