BOULDER, CO–(ENEWSPF)–April 24, 2010.Covidien (NYSE: COV) has initiated a voluntaryrecall of certain lots of its cuffed ShileyTM tracheostomy tubes andCustom/Specialty tracheostomy tubes due to the product’s cuff not holding air asa result of leaks in the pilot balloon inflation assembly. With respect to theaffected units, if a cuff does not hold air, ventilation will be adverselyaffected since the ability to generate positive pressure in the airway could becompromised by lack of cuff seal. This could result in a sudden decrease in theamount of oxygen in the blood or a sudden increase in the amount of carbondioxide in the blood, especially if the patient requires assisted mechanicalventilation. In some instances, this could result in serious injury, includingdeath.
