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BfArM publishes Bolton Medical field safety notice for TREO, RelayPro and RelayPlus aortic stent-graft systems

🇩🇪 BfArM field safety notices · Tue 10 Nov 2026

Germany's medicines and devices authority has posted an Urgent Field Safety Notice from Bolton Medical covering three aortic stent-graft products, with the manufacturer's Advisory Notice attached.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 10 November 2026 relating to the TREO, RelayPro and RelayPlus devices made by Bolton Medical. The notice is listed under reference 51230/26 and the product group "Non-active implants - special implants".

BfArM's listing does not describe the issue behind the notice or the actions it asks of users. It directs readers to the manufacturer's Advisory Notice, which is attached as a PDF of about 437KB.

The brief entry gives no details on affected lots, serial numbers, geographies or clinical consequences. Those details, if provided, will be in the Advisory Notice itself rather than in the BfArM summary.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action on a marketed medical device. Regulators such as BfArM publish these notices so that healthcare providers and other stakeholders can access them.

What it means for your team

  • Read the attached Bolton Medical Advisory Notice in full, since the BfArM listing gives no information on the defect or required actions.
  • Hospitals and vascular teams using TREO, RelayPro or RelayPlus should check whether their stock or patients are within the notice's scope.
  • Vigilance and quality teams should log the notice under reference 51230/26 and follow their internal field safety corrective action procedures.
  • Manufacturers and distributors with related products or customers should monitor for any further regulator communications.

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.

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