Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

The US Food and Drug Administration wants to alert you that, on April 23, 2010, Covidien initiated a voluntary recall of certain lots of its cuffed Shiley™ tracheostomy tubes and custom/specialty tracheostomy tubes. The recall is due to the cuff of the product not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected because the ability to generate positive pressure in the airway could be compromised by the lack of a cuff seal. This 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, especially if the patient requires assisted mechanical ventilation support. In some instances, this could result in serious injury, including death.

Health-care professionals and customers may report adverse events or quality problems experienced with the use of this product to the MedWatch, the FDA’s safety information and adverse event reporting program, either online or by regular mail, fax, or phone.

Online: www.fda.gov/medwatch/report.htm

Mail: Use postage-paid FDA Form 3500.
Mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787

Fax: 1-(800)-332-0178

Phone: 1-(800)-332-1088

For additional information and details on affected lots, please visit the FDA Web site.