Tracheostomy Tubes Pulled from the Market After Causing Babies and Children Serious Injuries

Medtronic is recalling lots of its Covidien Shiley tracheostomy tubes for babies and children after receiving reports that models made after November 29, 2012, caused some patients breathing difficulties and discomfort.

The world’s largest device manufacturer began notifying hospitals and distributors on May 8 that affected lots of Covidien Shiley tracheostomy tubes made with a wider-angle bend than previous models had resulted in 12 customer complaints of serious patient injuries, including breathing problems and discomfort. A doctor inserts the tube into the patient’s trachea (tracheostomy) to form an airway and assist the patient breathe. Reported breathing difficulties affected oxygen levels immediately upon tube placement. When the tubes were replaced with models made prior to November 29, 2012, the issues seemed to resolve, the FDA June 23 on its website.

Medtronic asked that customers and distributors quarantine and stop using the affected models of Covidien Shiley tracheostomy tubes and return the devices to the company as soon as possible for credit. Customers and distributors who provided the Covidien Shiley tracheostomy tubes to a homecare provider or patient were instructed to notify the primary care physician and the homecare provider that these products should be discontinued from use and returned. If the patient is not experiencing discomfort or breathing difficulties, the tube may be replaced with an alternative device at the next scheduled tube exchange.

Medtronic notified regulatory agencies around the world of the field action. Since November 29, 2012, Covidien Shiley tracheostomy tubes were shipped to Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the U.S, the FDA said.

The list of affected Lot numbers can be found here. Lot numbers will appear on the product labeling and the number is structured with the first two digits representing the year of manufacturing, i.e., 12 is for 2012, 13 is for 2013 and 14 is for 2014.

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