June 24, 2015 — Medtronic has issued a recall for Shiley tracheostomy tubes for infants and children after at least a dozen patients were seriously injured.

The Covidien Shiley tracheostomy tubes are inserted after a physician makes an incision in a patient’s trachea (windpipe) to open the airway, facilitate breathing, or clear secretions from the patient’s lungs.

About 70,000 of the tubes are being recalled and hundreds of adverse events have been reported, although only 12 were classified by Medtronic as “serious,” according to the Minneapolis Star-Tribune.

The problems began when the tube was re-designed in November 2012 to give it a wider angle. Adverse events included “breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.”

The Star-Tribune also reviewed adverse events reported to the FDA that describe it as unexpectedly losing air pressure:

“On March 9, for example, an unexpected deflation required an unidentified patient to be connected to a ventilator in a hospital intensive care unit, although the report did not classify that as a serious injury.”

For a list of products that were recalled, click here.

A spokesman for Medtronic said the company has enough pre-2012 tubes to meet demand. The company began notifying hospitals on May 8 that they should stop using the tubes. The products were manufactured in Mexico and distributed to 14 countries.


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