Primary source: Téléchargez le courrier de la société Dräger (04/09/2026)
Translated From French
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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.
Undetected cracks in the tubing may lead to reduced ventilation efficiency or treatment delays, potentially resulting in severe patient outcomes including desaturation or hypoxia.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
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