The Food and Drug Administration (FDA) has given the recall of Medtronic’s Shiley neonatal and pediatric tracheostomy tubes a Class I label, its most serious designation. Under a Class I label, the FDA believes that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Last month, the company announced the voluntary recall of over 70,000 tubes among eight separate product lines due to a 2012 redesign that widens the angle-bend of the tubes. The redesign has led to airway obstruction among infants and children. The Class I designation affects over 8,000 of the devices manufactured between May 2nd, 2013 and April 17th, 2015. The FDA has posted the lot numbers of the affected models on its website. Minnesota-based Medtronic, the leading medical device manufacturer in the world, announced that it has enough pre-2012 replacement tubes with the narrower design to accommodate the recall. Although no deaths have been reported from the tube’s design, 12 injuries and hundreds of adverse events have been reported to regulators.
In addition to the general discomfort, many of the adverse events stem from reports that the device suddenly loses air pressure causing oxygen deprivation and carbon dioxide saturation. The device is inserted into the windpipe during tracheostomy procedures, providing an airway that allows patients to breathe. Despite the severity of the defect, most of these events have not been classified as a serious injury due to quick action by medical professionals. Patient discomfort, on the other hand, is considered to be a serious injury according to the FDA. No cases of permanent injuries have been reported, however. According to Medtronic’s press release, it began informing hospitals and home care patients beginning on May 8th, “to quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.”
The devices were manufactured by Dublin-based Covidien, a company that Medtronic purchased for nearly $50 billion in January. Despite the acquisition, the combined company operates as a stand-alone, with the corporate headquarters remaining in Dublin, although some executive offices have been moved to Minnesota. The tubes are manufactured in Mexico, and sold in 14 countries, including the U.S. and Canada. The company announced that it has halted additional shipments of the recalled devices. The most recent Class I recall designation is the third such event for Shiley tubes. On May 6th, 2010, the FDA disclosed the recall of 52 versions of the tube involving over 400,000 devices due to 1,200 consumer complaints that the devices leaked air. Also in 2012, the company recalled over 330,000 tubes due to improper functioning of specific components in the device.
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