Covidien is recalling a number of tracheostomy tubes, used to help people breathe on ventilators, due to issues with the tubes leaking. The trach tube problem has resulted in at least 1,200 reported incidents, including at least three deaths.
The FDA announced the tracheostomy tube recall on April 23, warning that the cuff of the tubes do not always hold in air as they should. If the cuffs leak, it could adversely affect ventilation, decreasing the amount of oxygen being received by patients. This could lead to serious injury or death under some circumstances.
Covidien sent a letter to customers (pdf) on April 13, alerting them that it had received reports of “serious adverse health consequences” due to problems with some versions of its cuffed Shiley tracheostomy tubes, as well as some custom and specialty tracheostomy tubes. Covidien has told FDA that it has received reports of at least three deaths and 1,200 incidents connected with the recalled trach tubes, according to FDA officials.
In the affected units, the cuff does not hold air due to leaks in the pilot balloon inflation assembly. This can cause the ventilation system to lose the ability to create positive pressure in the airway, leading to a sudden decrease in the amount of oxygen being received by the patient, or a sudden increase in the amount of carbon dioxide in their blood.
The medical device recall affects 62 product codes and their associated lot numbers for Shiley Tracheostomy Products and Custom Shiley Tracheostomy Products, commonly referred to as “trach tubes”. All of the recalled devices were manufactured between November 2008 and December 2009. A complete list of the affected product codes and lot numbers is available in the FDA and Covidien press releases.
The FDA and Covidien are recommending that customers return any products affected by the recall. They can contact the company’s technical services department at 1-800-635-5267. Any healthcare professionals or patients who have experienced adverse events associated with this product should contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.