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| Medtronic recalled certain models of its Shiley tracheostomy devices--courtesy of Covidien |
Medtronic ($MDT) announced a large voluntary recall of its Shiley neonatal and pediatric tracheostomy tubes is underway due to a wider angle bend among affected models than in those manufactured after Nov. 29, 2012. It has suspended shipments of the faulty tubes.
There were 12 reports of serious injuries resulting from the product defect, including breathing difficulties that impacted oxygen levels immediately upon tube placement, according to a release. The device is inserted in a patient's windpipe during tracheostomy procedure, with a goal of providing an airway and facilitating the ability to breathe.
Eight product lines are affected, including cuffed and cuffless version of the device, as well as those packaged in disposable bedside trays. Medtronic's release lists the affected product and lots numbers, but not total number affected units of the device.
Medtronic inherited the Shiley tubes via its $50 billion acquisition of Covidien in January.
The company said that on May 8 it began instructing hospitals and distributors "to quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit," according to the release.
The hospitals and distributors are also supposed to tell the homecare provider and primary care physician of home healthcare patients to return the device. The physician should evaluate the tube's continued use among patients who are using it at home without discomfort. Regardless of the decision made, the device must be replaced at the next tube exchange, Medtronic says.
Since Nov. 29, 2012, the device has been shipped to Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the U.S.
More than 330,000 units of Shiley were recalled in 2012 "due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients," according to the FDA's database.
On May 6, 2010, the FDA disclosed a recall of 52 different versions of Shiley tubes that were made in Mexico. More than 400,000 units were recalled because of 1,200 complaints that they leaked air, resulting in inadequate ventilation.
Both of those recalls were classified as Class I, meaning the agency believes there is a reasonable probability that exposure to the device "will cause serious adverse health consequences or death."
The most recent recall has not yet been classified by the FDA in its recall database.
- read the Medtronic release
- here's the FDA safety alert
- see the product's recall history