Abre Venous Self-Expanding Stent System

Product Abre Venous Self-Expanding Stent System Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare

Medtronic is initiating this recall to inform customers of an update to the Instructions For Use (IFU) for the Abre™ Venous Self-Expanding Stent System (herein referred to as Abre). This update provides a validated manual deployment workaround method to help mitigate potential harms in the rare event customers experience a partial stent deployment; the method is included in the notification letter and the Abre IFU will be updated, pending regulatory approvals, to reflect this standardized approach.These instructions should only be followed in the event a partial stent deployment occurs. Medtronic is taking this action to reduce the severity of potential patient harms. The steps provided in the notification are intended to minimize the risk of serious adverse health consequences in the rare event of partial stent deployment.There are no product retrievals or disposals requested by Medtronic as part of this IFU update.

RA-82864