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Cordis Corporation is cautioning health care professionals about the use of the company's biliary stent, the PRECISE® RX Nitinol Stent Transhepatic Biliary System. The PRECISE RX stents are intended to treat obstructions in the bile duct due to malignancies. FDA has not cleared these stents for use outside the biliary tract. In fact, the stent's current labeling contains a warning that the device's safety and effectiveness in the vascular system have not been established.
Nonetheless, some physicians have used these devices in the vascular system. When used this way, air can be introduced into the patient by the stent system, and this can cause serious problems, including coma, seizure and stroke. In fact, we've had several reports of malfunction, and also of patient injuries due to air embolism, when this system is used outside the biliary tract.
On May 4, Cordis sent a notification to their customers describing these severe adverse events and advising them to limit the use of this device to the FDA-cleared uses only.