The FDA recently announced that approximately 70,000 children’s tracheostomy tubes have been recalled by Medtronic after it received hundreds of reports of issues with a recent redesign. The FDA stated that there have at dozen reports of serious injury from the new tubes, which have an angle that is too large for children’s small throats. In some cases the tubes have collapsed, causing a reduction in airflow to the child.
Medtronic is the world’s largest medical device company. It only recently acquired the designer of the tracheostomy tubes, Covidien, in January, 2015, for $49.9 billion dollars.
A tracheostomy is a hole through the neck and into a patient’s windpipe. A tracheostomy may become necessary when air is not getting to the lungs, in many cases, due to a blocked airway. A tracheostomy tube, or trach tube for short, is a curved tube that is inserted into the hole.
Early versions of the Covidien devices, known as Shiley Tracheostomy tubes, reportedly have not caused issues. The tubes were redesigned in November, 2012. Devices manufactured before that date are considered safe.
The following tracheostomy lot numbers and models are affected, according to the FDA. They are collectively known as Shiley Neonatal and Pediatric Tracheostomy tubes:
- Shiley Neonatal Tracheostomy Tube, Cuffless (Numbers 2.5-4.5, lots 12-14)
- Shiley Neonatal Tracheostomy Tube, Cuffed (Numbers 2.5-4.5, lots 12-14 and 15A0152JZX)
- Shiley Pediatric Tracheostomy Tube, Cuffless (Numbers 2.5.-5.5, lots 12-14)
- Shiley Pediatric Tracheostomy Tube, Cuffed (Numbers 2.5-5.5, lots 12-14 and 15A0151JZX)
- Shiley Pediatric Tracheostomy Tube, Long Cuffless and Cuffed (Numbers 5.0-6.5, lots 12-14)
If your child suffered a serious injury as a result of a faulty Shiley tracheostomy tube, you may be able to file a personal injury lawsuit on their behalf. Call today to discuss a possible lawsuit with a qualified personal injury attorney. The experienced attorneys at Lopez McHugh can help you determine if your child may have a tracheostomy tube lawsuit.