The Food and Drug Administration (FDA) has issued a class I recall of the Cordis PRECISE RX Stent. The PRECISE RX Stent is a bile duct stent, frequently used in vascular patients, that has led to comas, seizures, and strokes.

The PRECISE RX stent is a flexible tubular device that was designed to drain the biliary tract and keep the bile duct open. However, some physicians have used the stent in vascular patients. The FDA has not cleared this use.

Cordis Corporation, a division of Johnson & Johnson and manufacturer of the PRECISE RX Stent, had issued revised instructions, which had not been cleared by the FDA, on the use of the stent in vascular systems. The recall involves the revised instructions, and the FDA and Cordis strongly recommend that physicians limit the use of the stent to FDA-approved uses only.

According to the FDA, air may be introduced into the patient through the stent, which may cause coma, seizure, and stroke. Nine patients suffered injury due to air embolism.

A class I recall is the most serious type of recall. It involves situations where there is reasonable probability that a product will cause serious injury or death.