Covidien Shiley Tracheostomy Tube Recall Issued Due to Defects

Reports of problems involving leaks and disconnections have led to a recall of Covidien’s size 8 Shiley tracheostomy tubes. 

The Covidien Shiley tracheostomy tube recall was announced by the FDA and the manufacturer on August 4, after customers reported volume leakage and disconnection between the inner and outer cannula during mechanical ventilation.

Although there have been no reports of any injuries suffered by patients, health care professionals have been urged to replace any recalled tracheostomy tubes that are being used in patients as soon as clinically possible. Covidien recommends that if a doctor thinks it is better to leave the tube in place that they increase the frequency of direct patient observation.

The recall affects four batches of size 8 Shiley reusable cannula, cuffed adult tracheostomy tubes with product codes 8FEN and 8LPC. The lot numbers go from 0910000342 to 1101001558, 110201893X to 120600700X, 0910000346 to 1101001823, and 110200327X to 120600351X. The affected tubes were distributed from October 2009 through June 2012.

A tracheostomy tube is a catheter inserted in the trachea to provide a patient with an airway to assist in breathing. 

This is at least the second tracheostomy tube recall this year. In February, Smiths Medical issued a Bivona Neonatal, Pediatric and Flextend tracheostomy tube recall after reports that there were problems disconnecting them from accessories. The FDA declared the problem to be a Class I medical device recall, meaning the agency believed that the devices would result in severe injury or death of a patient.

Covidien officials say they have alerted customers by mail and have provided instructions on how to return the devices. The company says that replacement products will soon be available. Customers with questions can contact Covidien Technical Services at (800) 635-5267.

Patients or health care professionals who experience adverse events while using the defective tracheostomy tubes should report the incidents to the FDA MedWatch Adverse Event Reporting Program.