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Terminated

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.

FDA Recall Z-0324-2018 · Posted None

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2017-11-15
Date Terminated2019-11-04
Product Quantity511

Reason for Recall

Potential for cracked luer hubs

Firm Action

On November 15, 2017 the firm sent letter to their customers indicating the following: The purpose of this communication is to inform you of a potential leakage scenario with the S.M.A.R.T. Flex Biliary Stent System. The leak may occur due to potentially cracked hubs in some units from within the 29 lots listed in this letter. Inspection details: As stated in the Instructions for use, users are warned that the device should not be used if the outer sheath cannot be flushed. Inspect for leakage during preparation of the device. Leakage may be more likely in the affected product due to cracks in the luer. At time of actual flushing, if there is no leakage observed, the product may be safely used. Available Assistance: We can provide help if you have any questions regarding this Correction. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc. · 2012-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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