Contact Us

Cordis Precise RX Stent
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


Cell Phone 

Street Address 

Zip Code 



Date the device was implanted:

Do you know that the PRECISE RX Stent was used in your surgery?

Is the device still implanted?

What medical condition prompted the use of the device?

Did the Stent cause any of the following?

Please describe any problems or injuries caused by the product:

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

FDA: Bile Duct Stent Unsafe To Use In Vascular System

May 12, 2004 |

The use of a specific type of bile duct stent in vascular patients is considered unsafe, and the Food & Drug Administration has issued a class I recall to end the practice.

The stent is the PRECISE RX Stent, manufactured by Cordis Corporation. Cordis had 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.

The stent, a flexible tubular device, 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.

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.

Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo