Massachusetts-based Covidien has voluntarily recalled certain Shiley-branded tracheostomy tubes following 1,200 complaints that cuffs of the tubes were leaking air. The devices may be linked to three deaths, which are being investigated by the FDA.
Tracheostomy tubes help patients on ventilators breathe. But a leaking cuff 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, according to a statement from Covidien. An FDA spokesperson tells the Associated Press that the agency is looking into the deaths and is investigating whether manufacturing lapses contributed to the leaky cuffs.
A spokesperson for Covidien says that the company knows three patients on the tracheostomy tubes died, but that no further details are available. "[W]e have been unable to obtain detailed information about these incidents, so we cannot determine what role, if any, the product issue that led to this recall may have played," Sherri Hughes-Smith tells the AP.