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Covidien Shiley Tracheostomy Tube News

Medtronic, the manufacturer of the Covidien Shiley tracheotomy tubes has voluntarily recalled their neonatal and pediatric tracheotomy tubes. The Covidien Shiley tubes are for newborns and children. The problems surround the design that has a wider-angle bend than previous models and standard models. This is a voluntary recall for the tubes produced after November 29, 2012.

Covidien Shiley Tracheotomy Tubes Side Effects

The recall came from parents' complaints. Some noticed their babies suffering discomfort or breathing problems after placement of the tube. This wider-angle bend of the tube has been directly related to breathing problems of some newborns. The breathing difficulties observed can lead to decreased oxygen levels. Complaints were filed with Medtronic, who then notified the FDA. To date only 12 incidences of serious injury to newborns or children have been reported to Medtronic. Not every child that has used this tracheotomy tube has experienced problems.

Are Covidien Shiley Tracheotomy Tubes Safe?

Tracheotomy tubes are placed in the airway or windpipe found in the center front of the neck area around the area of the Adams Apple. These tubes provide an airway or assist the breathing of someone whose airway is unable to function or compromised. Unfortunately some of these tubes did not allow enough oxygen to flow. Your baby could sustain brain injury or even death if they lacks the proper oxygen levels over a sustained period.

There are many reasons why someone might need a tracheotomy. One example would be temporary damage or injury to the windpipe because of an accident. Someone suffering a severe allergic reaction might also need a tracheotomy.

A neonatal infant or child’s need for a tracheotomy includes these circumstances:
  • Early arrival of your newborn has resulted in his body not being fully developed. To help provide the necessary oxygen levels for your baby, your physician might have done a tracheotomy.
  • Some children have breathing problems due to a disease that produces thick mucus secretions. The child’s body cannot clear their airway and need frequent suctioning. In these cases a tracheotomy tube could help your child’s oxygen levels remain stable and not drop too low to cause problems.
There are many other medical reasons for the placement of a tracheotomy in your child. If you have any questions about why your child needed a tube, ask and keep asking until you do understand the necessity.

So what does this recall mean to you and your child, and what steps are being taken to correct the problem?

Medtronic has notified its customers (hospitals, home health agencies) and distributors. It's their job to notify your physicians or homecare providers who in turn are to notify you. Medtronic has taken action to ensure no further shipments of this product will be distributed anywhere in the world.

Consult your physician. Your physician should test your child to determine if there are any issues. They will make sure you child is not suffering from any discomfort, breathing difficulties due to the tracheotomy tube. If there are no signs of problems, your physician may determine it is safe to leave the tube in until the next tube change. This is a decision that you and your doctor must make together.

Please remember: not everyone who has used the Covidien Shiley tracheotomy tube has experienced these side effects. If your loved one used this tracheotomy tube and has had these side effects, you might need to contact a lawyer. You might need to file a lawsuit for any damages or the long term care of your child.

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