Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24537 |
| Brand Name: | Apollo_17202_IIb_BIB/ORBERA |
| Model: | Orbera Intragastric Balloon System: GRF-00283-00, BIB Intragastric Balloon System: GRF-00200-00 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | Apollo Endosurgery Inc |
| Issue: | The instructions for use (IFU) for the BIB and Orbera Intragastric Balloon Systems have been updated to communicate residual risks of gastric perforation and aspiration, two new adverse event types that were not previously listed in the IFUs for these products manufactured by Apollo Endosurgery |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/5/2019 |
