Neo-Tee Resuscitators Recalled Over Potential Ventilation Failure Risk

Mercury Medical has posted a Neo-Tee Resuscitator recall due to a defect that may impact patient ventilation.

The recall was initiated on August 30, 2024, and later posted by the US Food and Drug Administration (FDA) on October 2, 2024. Classified as a Class I recall, it involves a risk of inline controller detachment, which could prevent the delivery of positive pressure ventilation (PPV). Stemming from a manufacturing defect and traced to a missing step in production, this failure can lead to significant harm, including oxygen deprivation (ischemia) and potentially fatal outcomes.

This specific Neo-Tee Resuscitator recall applies to the Neo-Tee T-Piece Resuscitator, which is one of the devices used to deliver PPV in neonatal resuscitation. Mercury Medical has recalled specific part numbers, including 1050805 and 1050832, with affected lot numbers such as 2417650805, 2417750805 and 2423550832. In total, 1,300 units were distributed across medical facilities in states like Michigan, Florida, South Carolina, Pennsylvania and Indiana, and internationally to Albania.

On September 4, 2024, Mercury Medical issued an Urgent Field Safety Notice advising customers to check their inventories and stop using any affected products. Medical facilities were instructed to quarantine the recalled devices and contact Mercury Medical’s customer service to arrange for returns, replacements or credits. Upon the Mercury Medical recall, distributors were also notified to inform their customers and ensure the return of affected units.

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The Neo-Tee T-Piece Resuscitator is a gas-powered device used to provide emergency respiratory support to newborns and infants under 22 pounds. It works by delivering controlled ventilation through a face mask or tube in the patient’s airway.

T-piece resuscitators — which are widely recognized for their role in providing consistent ventilation pressure in neonatal resuscitation — fall under fixed pressure devices, which are designed to deliver controlled and stable pressures, improving respiratory outcomes compared to hand-driven pressure devices like self-inflating bags. According to a systematic review, T-piece resuscitators can help reduce complications such as bronchopulmonary dysplasia (BPD) and the need for intubation.

In neonatal care, resuscitation is typically required for about 10 percent of infants at birth, with around one percent needing intensive interventions. Resuscitation, which involves techniques such as PPV, is applied when newborns are apneic, gasping or their heart rate falls below 100 beats per minute within the first 60 seconds of life. The decision to initiate resuscitation is based on the infant’s breathing, heart rate and muscle tone immediately after birth.

While no injuries or deaths have been reported in connection with the Neo-Tee Resuscitator recall, it underscores the importance of ensuring high reliability in devices used for critical neonatal care, where consistent and controlled ventilation is essential.