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BfArM publishes urgent field safety notice for EPflex guidewires

🇩🇪 BfArM field safety notices · Mon 09 Nov 2026

Germany's medicines and devices regulator has listed an urgent field safety notice from EPflex Feinwerktechnik GmbH covering various guidewires, with details held in the manufacturer's advisory notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published on 9 November 2026 an Urgent Field Safety Notice from EPflex Feinwerktechnik GmbH. It covers guidewires (Führungsdraht) described only as "diverse", meaning various products.

BfArM lists the notice under the product group of injections, infusions, transfusions and dialysis catheters, with the reference number 49834/26. The regulator's web entry does not describe the problem, the affected models or lots, or what users are being asked to do.

Instead, BfArM directs readers to the manufacturer's Advisory Notice, attached to the entry as a PDF of 961 KB. That document holds the device-specific information. The file is flagged as not meeting accessibility standards.

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. Competent authorities such as BfArM make these notices available publicly.

What it means for your team

  • Hospitals, cath labs and distributors handling EPflex guidewires should obtain and read the full Advisory Notice under reference 49834/26 to establish whether their stock is affected.
  • Quality and vigilance teams should check the notice for the affected products, the issue and the required actions, as the BfArM page itself gives none of these.
  • Because the entry lists the products only as "diverse", scope should be confirmed against the manufacturer's document and not assumed from the web listing.

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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