Medtronic Recalls Breathing Tubes

Following reports of injuries, Medtronic plc is recalling certain affected lots of its Covidien Shiley tracheostomy tubes, which company officials claim were formed with a wider-angle bend than standard models manufactured after Nov. 29, 2012.

The device is inserted in a patient’s trachea, or windpipe, during a tracheostomy procedure to help provide an airway and facilitate breathing. The company said it began notifying hospitals and distributors in early May.

The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to Nov. 29, 2012 addressed the patient breathing difficulty or discomfort, according to the company.

The notification requested all customers 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.

Customers and distributors, who have provided the recalled Shiley tracheostomy tubes to a homecare provider or patient, must notify the primary care physician and the homecare provider that these products should be discontinued from use and returned.  If one of the recalled products is currently in use in a homecare patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, it is recommended that the patient`s physician evaluate the continued use. If the physician advises leaving the tracheostomy tube in place, the tube must be replaced with an alternate device at the next tube exchange.

Medtronic also took steps to prevent future shipments of the recalled products, in addition to notifying regulatory agencies around the world, as appropriate.  Since Nov. 29, 2012, Shiley tracheostomy tubes were shipped into Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States.

Dublin, Ireland-based Medtronic acquired the technology following the company’s recent acquisition of Covidien plc.