Cordis Precise RX Stent
The Cordis PRECISE RX stents are intended to treat obstructions in the bile duct due to malignancies. The 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, the stent system can allow air to enter the patient, which can cause serious problems, including coma, seizure and stroke. Several reports have arisen of malfunction, and also of patient injuries due to air embolism, when this system is used outside the biliary tract. Many of these cases exhibit medical malpractice and gross negligence of patient health.
On May 4, 2004, 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.
If you or a loved one has suffered an injury, illness or death, that seems to have been someone else's fault, call VanDerGinst Law at 1-866-843-7367 or click here for a FREE online case evaluation. The initial consultation is free of charge. If we agree to handle your injury case, we will work on a contingency fee basis, which means we get paid for our services only if, and when, there is a money recovery for you. In many cases a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. So please call right away to ensure that you do not waive your right to possible compensation.
