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Cordis Precise RX Stent

The FDA has issued a Class 1 recall of the Cordis PRECISE RX Stent. The PRECISE RX Stent is a bile duct stent which has frequently been used in in vascular patients which has lead to comas, seizures and strokes. Shortly after the recall, Cordis 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. 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. The PRECISE RX Stent, is manufactured by Cordis Corporation a division of Johnson & Johnson.

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. 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.

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