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U.S. Department of Health and Human Services

Safety

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PRECISE RX Nitinol Stent Transhepatic Biliary System

Audience: General surgeons and endovascular healthcare professionals

Cordis and FDA notified healthcare professionals of a Class 1 recall for the revised instructions for use, not cleared by the FDA, and contained in a notification mailed to Cordis' endovascular customers on March 29, 2004. Use of the stent system, indicated for treatment of obstruction of the bile duct due to malignancies, is reported to result in serious problems in some cases when used in the vascular system.

On May 4, 2004 Cordis sent a follow-up notification to customers describing nine patient injuries due to air embolism, including seizure and coma, as well as seven incidents of device malfunction in connection with the use of this system outside of its approved indication. Cordis stated that they were recalling the March 29, 2004 instructions with a strong recommendation that physicians limit their use of the PRECISE RX Stent to indicated uses only.

[May 04, 2004 - Recall Notice - FDA]