Covidien, a company that develops medical devices and supplies, is recalling a set of tracheostomy tubes that have been associated with three deaths recently. The FDA has also received about 1,200 complaints about these tubes.

A serious interruption of breathing can cause brain damage and can lead to death. According to Tom Gasparoli, an FDA spokesman, the three deaths of patients on these tracheostomy tubes are being investigated to see whether manufacturing problems in the tubes led to the failures of performance. The FDA is also investigating the 1,200 complaints.

Covidien, based in Mansfield, Massachusetts, has stated that the tubes being recalled have the brand name of Shiley and their defect is that the tube’s cuff is not holding air because of a possible leak in the pilot balloon. Without that reservoir of air, the patient could be suddenly deprived of oxygen or could suddenly have an increase of carbon dioxide.

Coviden spokeswoman Sherri Hughes-Smith has said that the company was informed of the three deaths.

  • “However,” she said, “We have been unable to obtain detailed information about these incidents, so we cannot determine what role, if any, the product issue that led to this recall may have played”.

What is a Tracheostomy?

A tracheostomy is an emergency procedure that places a tube directly into a patient’s windpipe (trachea) through an opening made in the throat. It is used for people on ventilators who are unable to breathe on their own, whether because of a facial injury or acute swelling that blocks the airway, or because they are comatose. The same procedure is called a tracheotomy (with no “s”) when it is designed to be more long-term and perhaps permanent.

There is a risk in performing a tracheostomy, which is possible damage to the nerves that control one’s vocal cords. There are two such nerves and damage to one will cause a voice problem, but damage to both will cause the patient to lose their voice.

  • This happened to the well-known British physicist Stephen Hawking, who came down with pneumonia in 1985 and his tracheotomy took what voice he still had after suffering from ALS (Amyotrophic Lateral Sclerosis) since he was 21. He uses an electronic voice synthesizer to speak.

Defective products are continually being recalled from the market. Our experienced product liability attorneys handle them and you can read more on our Product Liability page. They are usually complex cases and the first step is to consult a defective product attorney. Please see Starting a Product Liability Lawsuit for more details.

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