PV Bulletin

ANSM (France) - Safety information feed: Circuit de ventilation patient – VentStar Resus Neo et VentStar Resuscitaire – Dräger sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sécurité - Circuit

Dräger has issued a safety notice regarding potential leaks due to cracks in VentStar Resus Neo and VentStar Resuscitaire circuits.

Primary source: Téléchargez le courrier de la société Dräger (04/09/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

A safety action was registered with ANSM under number R2626181, notifying users about risks associated with VentStar devices and outlining a protocol for inspection of the circuits before use.

Why it matters

Undetected cracks in the tubing may lead to reduced ventilation efficiency or treatment delays, potentially resulting in severe patient outcomes including desaturation or hypoxia.

Action needed

Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

Relevant for
QPPVSignal Management Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 4, 2026

Full briefing

Practical implication

Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

Dräger has published a safety notification concerning the VentStar Resus Neo and VentStar Resuscitaire circuits due to identified risks of leaks caused by cracks. Users are urged to inspect the circuits before use to prevent patient safety risks.

What changed: A safety action was registered with ANSM under number R2626181, notifying users about risks associated with VentStar devices and outlining a protocol for inspection of the circuits before use.

Why it matters: Undetected cracks in the tubing may lead to reduced ventilation efficiency or treatment delays, potentially resulting in severe patient outcomes including desaturation or hypoxia.

Practical implication: Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-04T00:00:00.000Z
  • Discovered by monitor: 2026-09-04T21:36:01.378Z

Published from the regulator source ingestion pipeline after PV impact triage.

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