Abre Venous Self-expanding Stent System

Recalling firm

Medtronic New Zealand Limited

Product

Abre Venous Self-Expanding Stent System. [Device]. Model: All Models. Affected: All Lots

Reason

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.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-10-13

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/c1b66ecd-6d78-4dee-99d5-3d7ecc43dbbe