FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Endologix Recalls Nellix Sealing System, Ends Off-Label Uses

Jan. 8, 2019

Endologix announced a recall of its Nellix endovascular aneurysm sealing system and barred off-label use of the infrarenal abdominal aortic aneurysm treatment.

Recent data “leave us concerned that outcomes are suboptimal when the system is used outside current instructions for use,” said Endologix’s chief medical officer Matt Thompson.

The company’s actions mean that the product will only be available for pre-screened patients that meet the current indications.

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