Quality & complianceOfficial

BfArM lists urgent field safety notice for EPflex guidewires

🇩🇪 BfArM field safety notices · Fri 13 Nov 2026

Germany's regulator has published a manufacturer advisory on various EPflex Feinwerktechnik guidewires, but the listing itself gives no detail on the problem or the devices affected.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from EPflex Feinwerktechnik GmbH concerning guidewires (Führungsdraht) of various types. The entry is dated 13 November 2026 and carries the reference 49837/26.

BfArM files the notice under the product group of injections, infusions, transfusions and dialysis catheters. The listing refers readers to the manufacturer's enclosed advisory notice for details of the devices concerned, which is available as a 965 KB PDF.

The public listing does not state the nature of the issue, the specific models or batches affected, or the actions the manufacturer is asking users to take. Those points can only be established from the attached advisory notice, which has not been summarised here.

As general context, a field safety notice is the communication a manufacturer sends to customers or users when it takes a field safety corrective action in relation to a medical device on the market.

What it means for your team

  • Read the full EPflex advisory notice (reference 49837/26) to find out which guidewire products and which actions are involved.
  • Check inventory, procedure kits and clinical use for EPflex guidewires, as the listing describes the products only as 'various'.
  • Device-vigilance teams should log receipt of the notice and follow their internal procedures for documenting and acting on field safety corrective actions.
  • The BfArM listing alone is not enough to assess risk or scope, so avoid drawing conclusions before reviewing the manufacturer's document.

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 →