Medtronic Recalls Certain Lots of Neonatal and Pediatric Tracheostomy Tubes
On June 23, 2015 the U.S. Food and Drug Administration (FDA) posted a firm press release regarding the company Medtronic’s worldwide voluntary recall of certain neonatal and pediatric tracheostomy tubes.
Medtronic announced on May 8, 2015 that they began notifying hospitals and distributors that affected lots of the Covidien Shilley tracheostomy tubes had been developed with a wider-angle bend than standard models manufactured after November 2012.
The company issued the warning and voluntary recall after customer complaints, including instances of 12 serious injuries, were reported. The injuries reported included Medtronic tracheostomy infant injuries such as: breathing difficulties that affected oxygen levels and discomfort. The notification by Medtronic requested that all hospitals and distributors discontinue use of the affected lot and return them to the company for a credit.
All customers and distributors who have circulated the Covidient Shilley tube to homecare patients or providers have been asked to contact each patient’s primary care physician and home-care provider and alert them of the recall and possible side effects.
Since November 29, 2012, the Shilley tube has been distributed to Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Uruguay, Turkey, and the United States.
Visit the FDA website for a list of the specific lot numbers that have been recalled.
What is a tracheostomy?
A tracheostomy, sometimes referred to as a tracheotomy, is a surgical opening created through the neck into the trachea (or windpipe) to allow direct access to a breathing tube. A breathing tube is typically placed through this opening into the trachea in order to provide an airway, as well as to remove discharge from the lungs. This incision into the trachea may be temporary or permanent and it allows for breathing through the tube rather than through the nose or mouth of the patient. It is usually done in an operating room while under general anesthesia.
A tracheostomy is usually done for one of several reasons, including:
- Airway obstruction
- To safely deliver oxygen to the lungs
- To remove discharge or excretions from the lungs
All tracheostomies are performed due to an inability of oxygen to reach the lungs. Some reasons that the airway may be obstructed are:
- Subglottic stenosis
- Vocal cord paralysis
- Laryngeal injury or spasms
- Congenital abnormalities of the airway
- Burning due to inhalation of corrosive materials
- Obstructive sleep apnea
- Presence of foreign body
It is also possible that a tracheostomy is necessary due to lung issues or complications such as chronic pulmonary disease, need for prolonged respiratory support, injury to the chest, and injury or dysfunction of the diaphragm.
There are also several other contributing factors that may require a tracheostomy. You should speak with your child’s pediatrician to learn more about tracheostomies and when they are necessary.
How are tracheostomy tubes related to infant injuries?
There are many situations that may necessitate a neonatal or pediatric tracheostomy. The most common reason for a tracheostomy is to relieve severe breathing difficulties due to an obstruction or narrowing in the upper airway. Additionally, a tracheostomy may be needed for babies who have secretions, such as mucous, in their airway that prevent them from being able to properly swallow saliva, thus interfering with their breathing.
Unfortunately, as with most procedures, there are potential risks and consequences of having a tracheostomy done on your child.
If your child is currently experiencing breathing difficulties with a tracheostomy, it is important to bring this up to you child’s physician immediately. You should discuss the potential side effects and consequences of a tracheostomy with an experienced healthcare professional.
What steps should I take if my child has a Medtronic tracheostomy injury?
If your child has received or is currently receiving treatment that necessitates a neonatal or pediatric tracheostomy tube, there is a chance that the tracheostomy tube used in their treatment is part of the worldwide voluntary recall.
You should contact an attorney immediately to discuss your legal rights, as you may be able to receive financial compensation for the injuries that your child has as a result of a recalled tracheostomy tube.