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BfArM publishes Maquet Cardiopulmonary urgent field safety notice for Rotaflow Console

🇩🇪 BfArM field safety notices · Tue 27 Oct 2026

Germany's regulator has listed a manufacturer advisory on the Rotaflow Console, but the public entry does not describe the fault or the corrective actions required.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Maquet Cardiopulmonary AG concerning the Rotaflow Console. The entry is dated 27 October 2026 and carries reference 49546/26.

BfArM places the product in the group "Surgical equipment/Anaesthesia - surgical equipment". The listing itself gives no description of the issue, the affected devices or the actions users are expected to take.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached to the entry as a 1MB PDF. BfArM flags that the file does not meet accessibility standards. The nature of the defect is not stated in the text of the listing, so it cannot be characterised here.

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. Regulators such as BfArM then publish these notices for transparency.

What it means for your team

  • Teams with Rotaflow Consoles in their facilities should read the full Maquet Cardiopulmonary Advisory Notice via the BfArM entry, reference 49546/26, to establish the issue and required actions.
  • Quality and vigilance staff should not rely on the BfArM listing alone, as it contains no details on the fault, affected units or deadlines.
  • Organisations should check that the notice has reached the right internal recipients and that any response steps are documented.

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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