Medtronic (NYSE:MDT) said today that it is recalling certain lots of its Covidien Shiley tracheostomy tubes after receiving complaints and reports of serious injury. The company said it began notifying hospitals and distributors worldwide on May 8 of the issue.
The recalled tracheostomy tubes, manufactured after November 29, 2012, were formed with a wider-angle bend than standard models, the Fridley, Minn.-based medical giant said.
Medtronic said it received a small number of complaints over the tubes, including 12 serious patient injuries relating to breathing difficulties and discomfort upon tube placement.
The company said that replacing the tubes with devices manufactured before November 29 addressed the issues. The recall includes 8 product lines of tracheostomy tubes and multiple lot numbers, which are available on Medtronic’s press release.
Medtronic said it took steps to prevent future shipments of the recalled products and notified the appropriate regulatory agencies of the issue. The recalled tubes were distributed to Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the U.S., the company said.