Covidien plc (NYSE:COV) is voluntarily recalling some of its Shiley tracheostomy tubes over problems with the devices’ pilot balloons.
The Mansfield, Mass.-based medical products giant’s tubes are designed to keep patients’ airways open using small balloons through which breathing tubes pass. Some of the devices can malfunction due to "the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly," according to a Food & Drug Administration press release.
The problem could result in sudden decreases in blood oxygen or sudden increases in carbon dioxide in the blood, according to the release, which in turn could lead to serious injury or death. Covidien sent a letter to customers April 13 detailing the potential problems and instructing them to return any affected products for replacement.
A list of the affected products can be found on the FDA’s website.