Allurion Gastric Balloon

Allurion Gastric Balloon Recall Summary The Allurion Gastric Balloon, a weight-loss device, is being recalled because its instruction materials did not fully explain potential side effects, complications, how to check if the balloon passed naturally from the body, or that patients might vomit up the empty balloon at the end of treatment. The manufacturer has updated these instructions. This recall affects hospitals, pharmacies, and laboratories in New Zealand.

Recalling firm

Clinical & Regulatory Services Limited

Product

Allurion Gastric Balloon. [Device]. Model: Allurion Gastric Balloon System - model number 10D-AUS

Reason

The manufacturer recognises that the IFU and PIL did not contain sufficient detail on the following:, · all potential adverse events and complications, · information regarding examination of the stool to confirm excretion of the balloon, · reminder to patients that vomiting of the empty balloon at the end of residence can occur, The IFU and PIL have been updated

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-01-27

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/b5c0fe33-93ae-495f-b447-ed79f0dabf26