Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes

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Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes

06/23/2015 11:04 PM EDT

Medtronic (NYSE: MDT) announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.

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