Neo-Tee (ventilators)

2024: Recall of defective devices where controllers fall off

In early October 2024, the US Food and Drug Administration (FDA) announced the recall of the Neo-Tee ventilators of the American company Mercury Medical. In these devices, a defect has been identified that can lead to the death of patients.

Neo-Tee is a manual resuscitation device designed for newborns and children weighing up to 10 kg. The device is a breathing circuit with a built-in peak pressure controller on inhalation, a manual correction button and a T-shaped splitter with a pressure gauge. The device can be connected to any source of medical gas. The small weight and compact size of Neo-Tee allows resuscitation measures without the use of stationary equipment.

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Mercury Medical

The detected defect in Neo-Tee is associated with a malfunction of the built-in controller, which can lead to a loss of positive pressure. This can provoke serious adverse health effects, including damage due to lack of oxygen (ischemia) and death.

Mercury Medical is recalling Neo-Tee resuscitators due to the possibility of a breakdown of the built-in controller. Check for recalled products and stop using them, the FDA said in a notice.

About 1,300 Neo-Tee devices are subject to recall. Healthcare facilities are urged to stop using defective products and contact Mercury Medical customer service. The manufacturer will replace faulty ventilators with new ones or fully compensate customers for their cost. As of October 2024, there are no reports of injuries or deaths related to the use of defective Neo-Tee products.^[1]

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