CanadaWhat's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10120090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G14100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G14150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G16150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G18060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G18150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G20060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G20150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G12060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G14060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G14080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G16100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G18080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G18100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G14120090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G12080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G12100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G12150090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G16120090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G16080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G18120090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G20080090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G10040090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G16060090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G20100090
Affected products: Abre Venous Self-Expanding Stent System; Lot or serial number: All lots.; Model or catalogue number: AB9G20120090
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)