FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Medtronic Recalls Neonatal and Pediatric Tracheostomy Tubes

June 25, 2015

Medtronic is recalling certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes manufactured after Nov. 29, 2012, because they were formed with a wider angle bend than standard models.

The Irish devicemaker began alerting customers May 8 after receiving reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels immediately upon tube placement and discomfort when using the device.

To address the problem, the company advised replacement of the tubes with products manufactured before Nov. 29, 2012. The recall notice requested that customers immediately return all affected lots to the devicemaker.

The tubes were distributed in Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the U.S., the company said Tuesday.

Read the recall notice at www.fdanews.com/06-25-15-MedtronicTubeRecall.pdf.  — Jason Scott