Covidien Shiley Adult Tracheostomy Tubes: Class I Recall - Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae

AUDIENCE: Consumer, Health Professional, Home Care

ISSUE: FDA notified healthcare professionals that Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae, which were observed during mechanical ventilation of patients. Certain lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes are included in this product recall. All other sizes and styles of Shiley tracheostomy tubes are unaffected by this action. Affected tracheostomy tubes were manufactured and distributed from October 1, 2009, to June 26, 2012.

BACKGROUND: A tracheostomy tube is a prescription device used by the order of a physician. It is placed through the patient’s windpipe (trachea) during a surgical procedure called a tracheostomy to create an airway and provide a pathway to remove fluid from the trachea and lungs.

Inflatable cuff tracheostomy tubes have a soft balloon around one end of the tube that is inflated to seal off the space between the wall of the trachea and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the trachea.

RECOMMENDATION: Customers should return all Shiley tracheostomy tubes from the affected models and lots to Covidien. If one of the recalled tubes is already in use in a patient, Covidien recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, Covidien strongly encourages that the frequency of direct patient observation be increased.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315634.htm