FDA: Bile Duct Stent Unsafe To Use In Vascular SystemMay 12, 2004 | www.heartcenteronline.com
The use of a specific type of bile duct stent in vascular patients is considered unsafe, and the Food & Drug Administration has issued a class I recall to end the practice.
The stent is the PRECISE RX Stent, manufactured by Cordis Corporation. Cordis 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.
The stent, a flexible tubular device, was designed to drain the biliary tract and keep the bile duct open. However, some physicians have used the stent in vascular patients. This use has not been cleared by the FDA.
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.