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U.S. Department of Health and Human Services

Medical Devices

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Biliary Stents Instructions for Use

Class I Recall
Date Recall
Initiated:
May 4, 2004
Product:
PRECISE® RX Nitinol Stent Transhepatic Biliary System
Use:
Biliary stents are permanently implanted flexible tubular devices intended for use to treat bile duct obstruction due to malignancies. They function to drain the biliary tract and to keep the bile duct open. Uses outside of the biliary tract, i.e., in the cardiovascular or other systems, have not been cleared by the FDA.
Recalling Firm:
Cordis Corporation
14201 NW 60th Ave
Miami Lakes, FL 33014-2802
Reason for Recall:
Some physicians use this device for vascular use. This use has not been cleared by the FDA. When used this way, air may be introduced into the patient via the stent system causing serious problems including coma, seizure and stroke. There have been nine patient injuries due to air embolism and seven incidents of malfunction in connection with the use of this system outside of its approved indications. Cordis is recalling its revised instructions for use and strongly recommends that physicians limit the use of the PRECISE RX Stent to FDA-approved uses only.
Public Contact:
Hal Delgado
Executive Director, Quality Assurance
FDA District:
Florida
FDA Comment:
Physicians are informed in the current labeling warning statement that the “safety and effectiveness for use in the vascular system have not been established.” Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
  For additional information on this product recall, see the nearby links.