There is a company in Massachusetts that is recalling tracheostomy tubes that are used to help patients on ventilators breathe. There have been reports that three people have died while using them. The company told the FDA that there were also about 1,200 complaints of leak involving the recalled devices. The FDA is supposed to be investigating the complaints and death of the three people. The recall affects trach tubes placed in the patients’ throats that are on ventilators to help them breath better.
Covidien, the company, is recalling certain cuffed Shiley-branded custom trach tubes and also Shiley-branded custom trach tubes because the product’s cuff may not hold air due to a possible leak in the pilot balloon. Because of this, it could result in a sudden decrease in the amount of oxygen in the blook or a sudden increase in the amount of carbon dioxide that can lead to serious injury or even death.