A variety of tracheotomy tubes was recalled on July 8, 2004 because they can break apart in the neck, a defect linked with two deaths that prompted federal health officials to advise patients to get replacements. The recalled product is the Shiley TracheoSoft XLT Extended Length Tracheotomy tube. More than 73,000 were shipped to hospitals and other health organizations over the last four years.

There has been reports of part of the tube breaking in a way that could let it slide down into the neck and block breathing, said Food and Drug Administration (FDA) 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, nor—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.