Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29761 |
| Brand Name: | MITG - EverFlex Entrust Peripheral Stent |
| Model: | All Models |
| Affected: | All 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: | ev3 Inc |
| Issue: | The manufacturer is informing customers of an update to the Instructions for Use (IFU) for the EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System. This update provides a validated manual deployment workaround method to help mitigate potential harms related to the low risk of partial stent deployment. The steps provided below are intended to reduce or avoid the need for secondary or surgical intervention— in the event of partial stent deployment. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/7/2022 |
