Device Safety Information – DSI/2026/004

In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications such as gastric outlet obstruction, small bowel obstruction and gastric perforation. Prompt medical intervention is essential to manage these complications.

Allurion Technologies Inc. have updated documentation with new safety information. Field Safety Notice (FSN-01-2026) provides further details and should be read in conjunction with this Device Safety Information (DSI).