Quality & complianceOfficial

BfArM publishes urgent field safety notice for bess pro's aerstent TBY implant

🇩🇪 BfArM field safety notices · Mon 26 Oct 2026

The German regulator has posted a manufacturer advisory covering the aerstent TBY, a non-active special implant, but the public listing does not describe the issue or the affected products.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 26 October 2026 relating to the aerstent TBY, made by bess pro gmbh. The entry is filed under reference 49755/26.

BfArM lists the device in the product group "Non-active implants - special implants". The listing itself gives no further detail and directs readers to the manufacturer's enclosed Advisory Notice for information about the device.

The BfArM page does not state the nature of the problem, which lots or serial numbers are affected, or what actions users are being asked to take. The Advisory Notice is available as a 374KB PDF attached to the entry. BfArM flags that the file does not meet accessibility standards.

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. Regulators such as BfArM publish these notices so that healthcare providers and distributors can see them.

What it means for your team

  • Download and read the full bess pro gmbh Advisory Notice, as the BfArM listing does not describe the issue, affected products or required actions.
  • Quality and supply-chain teams should check whether aerstent TBY devices are held in stock or distributed within their networks.
  • Vigilance and clinical teams should check whether the device is in use and decide how to document receipt of and response to the notice under their own procedures.
  • Reference 49755/26 can be used to track the notice in internal records.

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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