Newborn Tracheostomy Tubes Recalled Worldwide

Medtronic is globally recalling lots of Covidien Shiley neonatal and pediatric tracheostomy tubes following reports of 12 serious patient injuries.

The manufacturer began notifying hospitals and distributors worldwide on May 8, 2015, that the recalled lots from 8 product lines were formed with a wider-angle bend than standard models and were made after November 29, 2012.

Medtronic’s replacement of these tracheostomy tubes with products manufactured before that date addressed customer complaints, which included reports of breathing difficulty that impacted oxygen levels immediately upon tube placement.

A Shiley tracheostomy tube is put through a neonatal or pediatric patient's trachea during a tracheostomy procedure to help facilitate the ability to breathe.

All customers and distributors of the product are advised to quarantine and discontinue use of potentially affected units and return them to Medtronic for credit. A full list of recalled lots can be found in the FDA’s advisory notice.

If a patient is not experiencing any discomfort, breathing difficulties, or any other issues related to a recalled tube, then the FDA recommends that the patient's physician evaluate its continued use. If the physician advises leaving the tracheostomy tube in place, then the tube must be replaced with an alternate device at the next tube exchange, the FDA stated.

Any issues with the use of the tracheostomy tubes should be reported to the FDA’s MedWatch Adverse Event Reporting program.