Allurion Gastric Balloon: Updated Safety Information Due To The Risks Of Gastric Outlet Obstruction, Small Bowel Obstruction And Gastric Perforation (dsi/2026/004)
Allurion Gastric Balloon Recall Summary The Allurion Gastric Balloon, a weight-loss device used in the United Kingdom, has been issued updated safety information because in rare cases it has failed to pass through the stomach and intestines normally, causing blockages or tears in the digestive system. The FDA is providing this alert to inform healthcare providers and patients about these potential complications. This notice applies to the device as distributed in the United Kingdom.
- Recalling firm
- Updated safety information due to the risks of gastric outlet obstruction
- Reason
- 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.
- Classification
- Unclassified
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2026-05-27
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/85c7c6d7-9afc-41a9-aa1e-e39c1200df28