Medtronic Abre Venous Stent Recall 2026 Adds Deployment Steps: Health Canada

Health Canada has published a Type II health product recall for the Abre Venous Self-Expanding Stent System, made by Medtronic Inc. The recall, listed under identification number RA-82864, covers all lots of the device and centres on an update to its Instructions For Use (IFU). Medtronic’s recall date is 2026-10-14, and Health Canada posted the notice on 2026-10-26.

The audience for the notice is healthcare, which means the information is aimed at the clinicians and facilities that use the stent system rather than at the general public.

Regulatory Response

Health Canada classified the action as a Type II recall and lists the issue as a medical device performance concern. The product falls under the cardiovascular category of medical devices. The listed company is Medtronic Inc., based in Minneapolis, Minnesota, in the United States.

According to the notice, Medtronic is initiating the recall to inform customers of an update to the IFU. The update adds a validated manual deployment workaround method. It is meant to help reduce potential harms in the rare event that a partial stent deployment occurs.

Products Affected by This Recall

The recall applies to every lot of the Abre Venous Self-Expanding Stent System. Health Canada lists 30 model or catalogue numbers, all marked ‘All lots’ in the notice:

AB9G10040090, AB9G10060090, AB9G10080090, AB9G10100090, AB9G10120090, AB9G10150090, AB9G12060090, AB9G12080090, AB9G12100090, AB9G12150090, AB9G14060090, AB9G14080090, AB9G14100090, AB9G14120090, AB9G14150090, AB9G16060090, AB9G16080090, AB9G16100090, AB9G16120090, AB9G16150090, AB9G18060090, AB9G18080090, AB9G18100090, AB9G18120090, AB9G18150090, AB9G20060090, AB9G20080090, AB9G20100090, AB9G20120090 and AB9G20150090.

The notice does not give a number of units affected, and it does not list UPC codes.

The Reason Behind the Recall

This is not a recall in the usual sense of a product being pulled from use. Medtronic is distributing a notification letter that describes a standardized manual deployment method. The Abre IFU will be updated to reflect the same approach, pending regulatory approvals.

The notice says the instructions should only be followed if a partial stent deployment occurs. Medtronic describes such an event as rare. The company says it is taking this action to reduce the severity of potential patient harms, and that the steps in the notification are intended to minimize the risk of serious adverse health consequences.

Who Is Affected?

Hospitals, interventional specialists and other healthcare professionals who use the Abre Venous Self-Expanding Stent System are the primary audience. Patients who have received an Abre stent are not asked to take any action in the notice. Anyone with questions about a specific procedure should speak with their healthcare provider.

Steps Consumers Should Take

• Keep the product available for use as directed. Medtronic is not requesting any product retrievals or disposals as part of this IFU update.
• Review the notification letter. The validated manual deployment workaround method is included in Medtronic’s notification letter.
• Use the new steps only if needed. The instructions apply only in the event of a partial stent deployment.
• Contact the manufacturer for more information. Health Canada advises contacting Medtronic if additional details are required.
• Report concerns. Health or safety concerns can be reported through the Government of Canada reporting page linked from the recall notice.

Quick Facts

• Product: Abre Venous Self-Expanding Stent System
• Company: Medtronic Inc.
• Recall number: RA-82864
• Recall class: Type II
• Recall date: 2026-10-14
• Published by Health Canada: 2026-10-26
• Lots affected: All lots
• Returns requested: None

From the Agency

Health Canada’s notice states that Medtronic is initiating the recall to inform customers of an update to the Instructions For Use for the Abre system. The agency also records that there are no product retrievals or disposals requested by Medtronic as part of this update. The recommended action for the audience is to contact the manufacturer if additional information is required.

Readers who want the full details can consult the official Health Canada recall page and Medtronic’s notification letter, which contains the complete manual deployment method.