Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26756 |
| Brand Name: | CS - CoreValve Evolut R_Low Risk |
| Model: | EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, EVOLUTR-34 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Core Valve LLC |
| Brand Name: | CS - CoreValve Evolut PRO_Low Risk |
| Model: | EVOLUTPRO-23, EVOLUTPRO-26, EVOLUTPRO-29 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Core Valve LLC |
| Brand Name: | SH - Medtronic Evolut™ PRO+ System |
| Model: | EVPROPLUS-23US, EVPROPLUS-26US, EVPROPLUS-29US, EVPROPLUS-34US |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Core Valve LLC |
| Issue: | The manufacturer has received reports of Evolut™ valve leaflet damage occurring following PID at a rate of 0.020%*. These complaints of damage to the bioprosthetic leaflets resulted in moderate or severe aortic insufficiency which were detected acutely or during follow up. These reported events required re-intervention (77%), conversion to surgery (19%), re-intervention followed by surgery (2%), or were treated conservatively (2%). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 23/10/2020 |
