Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27891 |
| Brand Name: | CS - CoreValve Evolut R_Low Risk |
| Model: | EnVeo PRO Delivery Catheter System - ENVPRO-14, ENVPRO-16, ENVEOR-N |
| 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: | |
| Affected: | Multiple lots |
| 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: | |
| Affected: | Multiple lots |
| 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 is recalling EnVeo™ R, EnVeo™ PRO and Evolut™ PRO+ Delivery Catheters with a manufacturing date before 11-JUL-2020. Due to actuator separation that may occur during valve loading on the delivery system, advancement, deployment or recapture of the valve. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/6/2021 |
