Last week, healthcare experts were notified by the US Food and Drug Administration (FDA) and the maker Coviden concerning a recall of specific lots of its cuffed Shiley tracheostomy tubes and custom/specialty tracheostomy tubes, because of the product's cuff malfunction to preserve air.

It has been said that the leaks in the pilot balloon inflation assembly led to the defect. Shortage of proper air pressure in the cuff may avert the cuff from sealing.

FDA spokesman Tom Gasparoli said that the Food and Drug Administration was informed by the company that there were nearly 1,200 objections of leaks relating the recalled devices.

MedWatch, the FDA's safety information and adverse event reporting program, stated, "this could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation’.

It is said that the charitable recall only influences certain lot numbers. Only Shiley tracheostomy tubes from lot numbers planned in the firm’s press release are influenced by this action.

Coviden said that a substitute product is obtainable.