Quality & complianceOfficial

BfArM publishes Medtronic urgent field safety notice for Abre venous stent system

🇩🇪 BfArM field safety notices · Mon 26 Oct 2026

Germany's medicines and devices authority has posted a Medtronic Urgent Field Safety Notice for the Abre Venous Self-expanding Stent System, with details held in an attached manufacturer advisory.

The Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice (FSN) from Medtronic Inc on 26 October 2026, covering the Abre Venous Self-expanding Stent System. The notice is listed under reference 48220/26.

BfArM classifies the product in the group of non-active implants, specifically special implants. Its web entry does not describe the problem prompting the notice or the actions required of users.

Instead, the authority directs readers to the manufacturer's Advisory Notice, supplied as a PDF of 459KB attached to the listing. Any information on the nature of the issue, affected devices and corrective measures is therefore contained in that document, not in the BfArM summary.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action for a medical device already on the market. Regulators such as BfArM publish these notices so that users can see them.

What it means for your team

  • Obtain and read Medtronic's Advisory Notice, as the BfArM entry gives no detail on the issue or required actions.
  • Check inventory and implant records for Abre Venous Self-expanding Stent System units, and confirm whether the notice applies to them.
  • Vigilance and quality teams should log the notice under BfArM reference 48220/26 and document any response or corrective action taken.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

More Quality & compliance All →