|Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes|
DUBLIN - June 23, 2015 - Medtronic (NYSE: MDT) announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012.
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 November 29, 2012 addressed the patient breathing difficulty or discomfort. 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 the necessary steps to prevent future shipments of the recalled products. The company also notified regulatory agencies around the world, as appropriate. Since November 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 of America.
A Shiley tracheostomy tube is put through a patient's trachea (windpipe) during a tracheostomy procedure to help provide an airway and facilitate the ability to breathe.
The recall includes specific lots from the following eight product lines that were manufactured after November 29, 2012.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.