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BfArM publishes Urotech field safety notice for Renodrain Nephrostomie catheter

🇩🇪 BfArM field safety notices · Wed 11 Nov 2026

Germany's regulator has posted an urgent field safety notice from Urotech GmbH on its Renodrain Nephrostomie device, but the public listing gives no details of the problem.

The Federal Institute for Drugs and Medical Devices (BfArM) published an urgent field safety notice from Urotech GmbH on 11 November 2026. It concerns the company's Renodrain Nephrostomie device and is filed under reference 50559/26.

BfArM lists the product in its group for injections, infusions, transfusions and dialysis, specifically catheters. The listing points readers to the manufacturer's advisory notice for further information and details of the device, which is attached as a 165KB PDF.

The BfArM web entry does not describe the defect or hazard, the affected lots or serial numbers, or the actions Urotech is asking users to take. Those details are in the manufacturer's advisory notice, which is not reproduced in the published text.

As general context, a field safety notice is the communication a manufacturer sends to customers and users when it takes a field safety corrective action on a marketed medical device. National competent authorities such as BfArM make these notices publicly available.

What it means for your team

  • Hospitals, urology departments and distributors that hold Renodrain Nephrostomie products should read the full Urotech advisory notice to establish whether their stock or patients are affected.
  • Quality and vigilance teams should check the notice for the specific defect, affected lots and requested actions, since the BfArM listing does not state them.
  • Teams should log the notice under reference 50559/26 and follow their usual field safety corrective action procedures once they have reviewed the manufacturer's instructions.

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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