Parker, Waichman, Alonso LLP

Home » Topics » Defective Medical Devices » Shiley TracheoSoft

Shiley TracheoSoft

A variety of tracheotomy tubes has been recalled because they can break apart in the neck, a defect associated to two deaths that prompted federal health officials to advise patients to get replacements. The recalled product is the Shiley TracheoSoft XLT Extended Length Tracheotomy tubes. More than 73,000 were shipped to hospitals and other health organizations over the last four years.

There has been 17 reports of part of that tubing breaking in a way that could let it slide down into the neck and block breathing, said Food and Drug Administration officials. Two of the reports involved patient deaths and a third an injury. The FDA said there's no way to know how many of the recalled tubes currently are implanted into patients or because the disposable tubing is supposed to be replaced monthly are being stored in their homes.

The tubing can be used on patients hooked to ventilators, in which case an alarm is supposed to sound if breathing is blocked. But tracheotomy recipients aren't necessarily hospitalized or even bed-bound, and quick action is required to restore breathing if the tubing breaks, Foreman said. This is not standard tracheotomy tubing but a brand specially designed for certain patients who need a longer-than-usual version.

Other extended-length brands are available, the FDA said. The defect's cause hasn't been determined, and the recall covers all lots of that brand.

If you or a loved one suffered injuries from a Shiley TracheoSoft tube, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.