Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36503 |
| Brand Name: | Allurion Gastric Balloon |
| Model: | Allurion Gastric Balloon System - model number 10D-AUS |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | Allurion Technologies Inc |
| Issue: | 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 |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/1/2026 |
