KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, manufactured by Halyard Health of Roswell, GA, were recalled because the product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death. An endotracheal tube is a plastic tube that is inserted into the windpipe (trachea) through the mouth or nose to open an airway for mechanical breathing. Also, an endotracheal tube can also be used to remove fluid that builds up in the windpipe during a procedure.
The cuff inflation line of certain KimVent Microcuff Endotracheal tubes may detach from the tube during use if pulled, tugged, or if excess tube or patient movement occurs. If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs.
The firm received 19 reports stating the device malfunctioned. In most cases the problem was identified immediately, while in other cases, it was identified when ventilator alarms went off. Most patients required reinsertion of endotracheal tubes.
The affected product was manufactured from November 15, 2013, to October 21, 2014, and distributed worldwide from December 20, 2013, to October 30, 2014. There are 250 cases (10 tubes/case) involved with product code 13220.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe
See also Medical Law Perspectives, December 2012 Report: When Urgency Leads to Errors: Liability for Emergency Care