Device safety informationMHRA
Allurion Gastric Balloon safety warning over a safety concern
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.
What to do now
The MHRA has published safety information about Allurion Gastric Balloon.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/004). Quoted as issued.
Summary
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.
The risk
Summary 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).
Advice for healthcare professionals
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).
remain vigilant and inform patients of the signs and symptoms of gastric outlet obstruction, small bowel obstruction and gastric perforation associated with the Allurion Gastric Balloon
act promptly to prevent serious complications, including early referral or review for symptomatic patients
familiarise yourself with the new safety information and materials as described in FSN-01-2026
a Patient Information Card should be completed at the initial appointment and given to the patient at the time of device placement
essential product and safety information can be accessed in the Physician Guidance Document. This document is available through the Allurion mobile app, the QR code on the Patient Information Card or the link in Table 1 below
ensure any device that has not performed as intended and/or is involved in an adverse event is returned to Allurion Technologies Inc. for evaluation. Please report details of the event to Allurion Technologies Inc. at FSN@allurion.com and the MHRA via the Yellow Card Scheme
seek medical attention immediately if you experience symptoms such as severe or persistent abdominal pain, vomiting, nausea, swollen abdomen, or breathing difficulty, as these could be symptoms of gastric outlet obstruction, small bowel obstruction or gastric perforation
always carry your Patient Information Card with you. Show it to any healthcare professional who treats you, especially if you are at a different hospital from where the device was placed and you feel unwell
if you experience any side effects or issue with your balloon, don’t throw it away when it has passed and ensure that you return it to your healthcare professional
if you suspect that you’ve had a side effect related to the Allurion Gastric Balloon report it to the MHRA via the Yellow Card website
Advice for patients
seek medical attention immediately if you experience symptoms such as severe or persistent abdominal pain, vomiting, nausea, swollen abdomen, or breathing difficulty, as these could be symptoms of gastric outlet obstruction, small bowel obstruction or gastric perforation
always carry your Patient Information Card with you. Show it to any healthcare professional who treats you, especially if you are at a different hospital from where the device was placed and you feel unwell
if you experience any side effects or issue with your balloon, don’t throw it away when it has passed and ensure that you return it to your healthcare professional
if you suspect that you’ve had a side effect related to the Allurion Gastric Balloon report it to the MHRA via the Yellow Card website
Open the MHRA notice
Questions
Why has Allurion Gastric Balloon been recalled?
The MHRA has published safety information about Allurion Gastric Balloon. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.