Hundreds of Adverse Event Reports Trigger Recall of 70,000 Tracheostomy Tubes

A worldwide recall of 70,000 Covidien Shiley tracheostomy tubes intended for babies and children has been issued by Medtronic, the largest medical device manufacturer in the world. The recall was issued after the U.S. Food and Drug Administration (FDA) began receiving reports that some patients were having difficulty breathing with the tubes.

Regulators have received hundreds of adverse event reports concerning the tubes since 2012, when the devices were altered to give them a wider angle. Medtronic issued a statement Tuesday that  switching back to models predating the design change seemed to solve the young patients’ breathing problems. StarTribune obtained a copy of the statement.

Medtronic spokesman John Jordan told StarTribune that the company has enough of the pre-2012 Covidien Shiley tracheostomy tubes in stock to replace the recalled models. On May 8, the company started notifying hospitals that they should stop using the newer versions of the eight different variations of the tubes, including for patients who may be on home care.

Physicians use a tracheostomy tube to intubate a patient after they have made an incision in the individual’s trachea to create an airway or remove secretions from the lungs. Medtronic said that the Covidien Shiley tracheostomy tubes are disposable and patients who are not struggling to breathe may wait to have their tubes switched until their next regular tube change, according to StarTribune.

The FDA has received numerous reports of the Covidien Shiley tubes “unexpectedly losing air pressure.” A young patient needed to be connected to a ventilator and transported to an intensive care unit (ICU) on March 9 after an unexpected deflation took place. In its statement, Medtronic said there have been 12 serious patient injuries that led to the global recall, including breathing difficulties that immediately affected oxygen levels. “Discomfort” is considered a serious patient injury in cases like these, Jordan told StarTribune.

The Mexican-made Covidien Shiley tracheostomy tubes were sold in 14 countries including the U.S. and Canada. Dublin-based medical device maker Covidien designed the tubes. Medtronic, the largest medical device company in the world, acquired Covidien in late January, StarTribune reported.

 

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