Covidien has initiated a voluntary recall of certain lots of its cuffed Shiley tracheostomy tubes and Custom/Specialty tracheostomy tubes because the devices may have a defect that can render them dangerous in some situations.

A tracheostomy (trach) tube is a curved tube that is inserted into a tracheostomy stoma, or the hole made in the neck and windpipe to help patients on ventilators breathe. According to the company’s press release, the tracheostomy tube was recalled due to the product’s cuff not holding air as the result of leaks in the pilot balloon inflation assembly. If a cuff cannot hold air, ventilation will be adversely affected, resulting in the 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. In some cases, this could result in serious injury, including death.

Covidien told the Food and Drug Administration (FDA) that it received about 1,200 complaints of leaks involving the recalled devices. FDA spokesman Tom Gasparoli told the Associated Press that it is also “investigating the circumstances surrounding the deaths of three patients that may be associated with leaks in the tracheostomy tubes made by Coviden.”

Covidien spokeswoman Sherri Hughes-Smith said they received reports of the deaths in patients using the devices but that they had been unable to obtain detailed information about the incidents to determine whether the defective tubes may have played a role in the deaths.

Health care professionals are advised to report any adverse events or quality issues with this or any other medical device to the FDA’s MedWatch Adverse Event Reporting program at www.FDA.gov/MedWatch.