A Massachusetts company is recalling tracheostomy tubes used to help patients on ventilators breathe after receiving reports that three people died while using them. The company told the FDA that there were also about 1,200 complaints of leaks involving the recalled devices. The FDA is investigating the deaths and complaints. The recall affects tracheostomy tubes placed in patients’ throats to help them breathe on ventilators.

Covidien is recalling certain cuffed Shiley-branded tracheostomy tubes and Shiley-branded custom tracheostomy tubes because the product’s cuff may not hold air due to a possible leak in the pilot balloon. 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 that can lead to serious injury or death.