Database updated: 19 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:37708
Brand Name:Abre Venous Self-Expanding Stent System
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:Medtronic Inc
Issue:The manufacturer has received reports of partial stent deployments. Most events resulted in no or minimal patient harm, although some required additional intervention, including endovascular procedures, surgical conversion, or extended medical treatment.
An update to the Instructions for Use (IFU) for the Abre™ Venous Self-Expanding Stent System has been issued. This update provides a validated manual deployment workaround method to help mitigate potential harms in the rare event they experience a partial stent deployment.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/10/2026
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /