Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20461 |
| Brand Name: | Medtronic Core Valve Evolut R System |
| Model: | |
| Affected: | ENVEOR-L, ENVEOR-L-C |
| 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: | There is the potential for vascular trauma with the use of the Medtronic EnVeo™ R Delivery Catheter System (DCS). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 11/8/2016 |
