Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36525 |
| Brand Name: | INSPIRIS RESILIA Aortic Valve |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | Magna Ease 3300TFX |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve system |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided. |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | KONECT RESILIA Aortic Valved Conduit |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | MITRIS RESILIA Mitral Valve |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided. |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | Magna 3000/3000TFX |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided. |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Transfemoral Kit |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided. |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Brand Name: | 2900 |
| Model: | |
| Affected: | Patient Implant Cards (PIC) previously provided. |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Issue: | Edwards Lifesciences has identified an error on certain Patient Implant Cards (PIC) previously provided. The errors may relate to incorrect models, size or serial numbers, or a combination of these. This error is only associated with the implant card information and has no impact on the function of the implanted device. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/2/2026 |
