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Medtronic updates Abre venous stent instructions with manual expansion option for partial deployment

🇳🇱 IGJ · Sun 01 Nov 2026

Medtronic has issued a field safety notice for the Abre self-expanding venous stent system, adding an approved manual-expansion workaround for the rare event of partial stent placement.

Medtronic has told users of its Abre self-expanding venous stent system that the product's instructions for use have been updated. The change was communicated through a field safety notice dated 16 October 2026 and published by the Dutch health inspectorate, IGJ, on 2 November 2026.

According to the notice, the update provides an approved alternative solution based on manual expansion. Its purpose is to limit the potential harmful consequences if a stent is only partially deployed, which Medtronic describes as a rare occurrence.

The notice is a manufacturer warning. Medtronic B.V. is named as the authorised representative. The published document runs to six pages. The source text does not give further details on the number of events, affected lots or patient outcomes, and does not describe the manual expansion technique itself.

Under EU rules, manufacturers must monitor their devices after they are placed on the market and take action where users may be at risk. They inform users and the inspectorate through a field safety notice.

What it means for your team

  • Clinical and procurement teams using Abre should obtain the revised instructions for use and confirm that staff are working from the current version.
  • Quality and vigilance teams at hospitals should check how the field safety notice is being acknowledged and logged internally.
  • The full notice should be consulted for the technique details, scope and any required user actions, as the IGJ summary does not set these out.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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