Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated Recalled by Cordis Corporation Due to Potential for cracked luer hubs

Date: November 15, 2017
Company: Cordis Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.

Affected Products

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

Quantity: 511

Why Was This Recalled?

Potential for cracked luer hubs

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cordis Corporation

Cordis Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report