Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37527 |
| Brand Name: | Gore CARDIOFORM Septal Occuder |
| Model: | |
| Affected: | Catalogue Number - GSXE0020B, GSXE0025B, GSXE0030B |
| Software version: | |
| Recalling Organisation: | W. L. Gore & Associates (NZ) Limited The Vero Centre Level 25 48 Shortland Street Auckland 1010 |
| Contact Information: | |
| Manufacturer: | W L Gore & Associates Inc |
| Issue: | The manufacturer has identified that some GORE CARDIOFORM Septal Occluder delivery systems may be missing the guidewire port. This issue may result in an inability to prepare or introduce the device, potentially leading to increased procedure time. For devices that have already been implanted, no adverse events or complications related to this issue are anticipated. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 15/9/2026 |
