The U.S. Food and Drug Administration (FDA) issued an early alert regarding a potentially high-risk device issue involving specific VentStar Resus Neo breathing circuits manufactured by Draeger, according to federal safety notices. The disposable breathing circuits, designed to convey breathing gas to infants weighing up to 22 pounds, face potential risks of restricted ventilation or delayed therapy due to cracked or detached hoses.
According to the FDA Center for Devices and Radiological Health (CDRH) safety communication, Draeger distributed a letter to affected customers recommending that specific VentStar Resus Neo hoses be removed immediately from clinical use or inventory. The manufacturer initiated the advisory after receiving reports of obvious cracks discovered by users prior to patient application. While the disposable circuits are utilized in critical and emergency care settings, Draeger reported no serious injuries or deaths tied to the defect as of August 27, according to FDA documentation.
Clinical Risks and Device Mechanics
The VentStar Resus Neo functions as a disposable breathing circuit engineered to transport medical gases to neonatal patients. If a clinician attempts to use a compromised circuit, the affected hose may crack, leak, or detach entirely during operation. According to federal regulators, these structural failures can restrict critical ventilation or delay essential therapy, potentially causing patient desaturation, hypoxia, or death.
The FDA classifies the situation as a high-risk device concern due to the vulnerable patient population and the emergency contexts in which the equipment operates. Healthcare providers are instructed to thoroughly inspect all target hoses for physical damage prior to patient use, strictly following the manufacturer’s Instructions for Use (IFU).
Required Safety Actions for Healthcare Providers
Under the safety recommendations issued by Draeger on September 1, clinical staff must inspect breathing circuits before deployment in any care environment. Personnel identifying products with visible surface cracks or detached components must discard the items immediately without returning them to the manufacturer, according to the FDA advisory.
U.S. facilities or medical professionals seeking product clarification, quality assistance, or wishing to report adverse events can reach Draeger representatives directly at 445-224-0698 or via email at karina.howard@draeger.com. Additionally, the FDA encourages healthcare professionals and consumers to submit adverse event reports or quality complaints through MedWatch, the agency’s safety information and adverse event reporting program.
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