Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23606 |
| Brand Name: | Ovation Prime and iX |
| Model: | Ovation iX Abdominal Stent Graft System Platform |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Endologix New Zealand Co. Level 27 88 Shortland Street Auckland 1010 |
| Contact Information: | |
| Manufacturer: | Endologix International BV |
| Issue: | The manufacturer has identified an increase in intra-operative polymer leaks with the Ovation iX Abdominal Stent Graft System. The observed events may be associated with a hypersensitivity response to liquid polymer. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 19/9/2018 |
