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BfArM publishes Medtronic urgent field safety notice for MyPTM App

🇩🇪 BfArM field safety notices · Mon 02 Nov 2026

Germany's medicines and devices authority has listed an urgent field safety notice from Medtronic Inc for its MyPTM App, a medical app; 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 Medtronic Inc on 2 November 2026. It covers the MyPTM App, which BfArM classifies under medical data processing software, specifically medical apps.

The entry carries the BfArM reference 07465/25. BfArM's listing itself gives no description of the problem, the software versions affected, the number of users or devices involved, or the actions Medtronic is asking users to take.

Instead, the authority directs readers to the Advisory Notice that Medtronic issued, which is attached to the entry as a 2MB PDF. Those details are therefore not available from the BfArM web text alone.

As general context, a field safety notice is the manufacturer's communication to users when it takes a field safety corrective action for a device on the market. Regulators such as BfArM publish these notices so that healthcare providers and other affected parties can see them.

What it means for your team

  • Download and read the full Medtronic Advisory Notice via the BfArM listing (reference 07465/25) to establish the issue, the affected versions and the required actions.
  • Organisations that use or supply the MyPTM App should check whether their installations or users fall within the notice's scope.
  • Quality and vigilance teams should record receipt of the notice and track any corrective actions in line with their internal field-action procedures.

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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