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BfArM publishes Vascutek field safety notice for Gelweave vascular prosthesis

🇩🇪 BfArM field safety notices · Fri 13 Nov 2026

Germany's BfArM has listed an Urgent Field Safety Notice from Vascutek Ltd on its Gelweave Vascular Prosthesis; the details sit in the manufacturer's Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from Vascutek Ltd on 13 November 2026. It concerns the company's Gelweave Vascular Prosthesis and is filed under reference 51231/26.

BfArM classifies the product in the group of non-active implants, specifically special implants. The listing itself gives no description of the problem, the affected lots or the actions required. It refers readers to the manufacturer's Advisory Notice, which is attached as a 290KB PDF.

Because the public entry contains no further detail, the nature of the issue, the scope of the affected products and any corrective measures cannot be established from the listing alone. Field safety notices are issued by manufacturers to inform users of actions taken or recommended in relation to a device already on the market, and regulators typically publish them so that healthcare facilities and other stakeholders can access them.

What it means for your team

  • Obtain and read the full Vascutek Advisory Notice via the BfArM listing (reference 51231/26) to determine whether any stock or implanted devices are affected.
  • Quality and vigilance teams at hospitals and distributors should check inventories of Gelweave products once the affected scope is confirmed in the notice.
  • Do not rely on the BfArM listing for the technical issue or required actions; it does not describe them.

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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