The U.S. Food and Drug Administration (FDA) and Nellcor/Tyco Healthcare announced the recall of a brand of tracheotomy tubes because of a defect that has been linked to serious injury and two patient deaths. According to the FDA, there have been more than a dozen reports of the tubes breaking apart and threatening to slide down the neck which may block a patient's breathing. The recall involves over 70,000 Shiley TracheoSoft XLT Extended Length tracheostomy tubes shipped to hospitals since 2000.
The FDA is concerned because many of the tubes are kept in patients' homes and it may be difficult to determine exactly how many of the devices are currently implanted. The extended-length brand is replaced monthly. Because many recipients are not hospitalized, the tubes pose a serious risk if a patient's breathing becomes blocked and emergency assistance is required. Health officials have yet to determine the cause of the defect.
If you have suffered injuries due to a defective Shiley TracheoSoft tracheostomy tube, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Medical Devices & Implants
- Breathing: Overview
- Lung & Airway Disorders