FDA: Class I recall of Medtronic’s Covidien Shiley pediatric trach tubes

Editor's Note

The Food and Drug Administration on June 15 issued a Class I recall, the most serious, of certain Covidien Shiley neonatal and pediatric tracheostomy tubes by Medtronic.

The recalled tubes were formed with a wider-angle bend than standard models.

The company has received reports that patients switching tubes from a previous Shiley model experienced airway obstructions because of the wider angle. Airway obstructions can cause dangerous oxygen deprivation and carbon dioxide saturation.

The FDA has received 12 reports of serious injuries, but no deaths.

UPDATED 07/15/2015] Recall classified by FDA as Class I. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead. Required actions for customers added- Quarantine and discontinue use of the affected devices, Return affected product using the instructions in the Recall Notice.