Following at least 12 reports of problems involving serious injuries for patients, Medtronic is recalling some tracheostomy tubes designed for both adults and children.
A Medtronic Covidien Shiley tracheostomy tube recall was announced on June 23, in a Medtronic press release that indicates devices from eight different product lines may contain manufacturing defects. Tubes made after November 29, 2012 may have a wider-angle bend than standard models.
Medtronic reports that it received a number of complaints involving problems with the tracheostomy tubes, including at least 12 incidents that involved serious patient injury. These included breathing difficulties that affected patient oxygen levels as soon as the tube, designed to assist in breathing, was placed into patients. The company also said it received reports of discomfort associated with the use of the tracheostomy tubes.
The Covidien Shiley tracheostomy tubes are placed through a patient’s windpipe during tracheostomy procedures. They provide the patient with an airway and allow the patient to breathe.
According to the recall notice, Medtronic first notified hospitals and distributors that there was a problem on May 8. In the notification, the medical device manufacturer requested that all its customers and distributors check their inventory for the recalled tubes, discontinue use and quarantine all affected devices. The company asked them to return the recalled tracheostomy tubes as soon as possible in return for credit with the company.
The recall affects multiple lots of a number of devices, including: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Long Cuffless, Shiley Neonatal Tracheostomy Tube with TaperGuard Cuff, Shiley Pediatric Tracheostomy Tube with TaperGuard Cuff, Shiley Pediatric Tracheostomy Tube Long with TaperGuard Cuff, Shiley Neonatal Tracheostomy Tube Cuffless, Disposable Bedside Tray, and Pediatric Tracheostomy Tube Cuffless, Disposable Bedside Tray. A complete list of product numbers and lot numbers is available in the Medtronic press release.
Medtronic says it has contacted regulatory agencies worldwide. The company notes that the devices have been shipped to Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the U.S. since November 29, 2012.
Customers with questions can contact medtronic Post Market Vigilance by email at HQTSWEB@COVIDIEN.COM, or they can call the Medtronic Post Market Vigilance at: 800-635-5267 option 1, option 1, and again option 1.
The company recommends that adverse events involving these products be submitted to the FDA through its MedWatch, adverse event reporting system.