Z-0324-2018Class II

Cordis S.M.A.R.T. Flex Biliary Stent System

Name: Z-0324-2018 Cordis S.M.A.R.T. Flex Biliary Stent System
Creator: Cordis Corporation
Published: 2017-11-15
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2017-11-15 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of 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 on 2017-11-15. FDA classified it as Class II and gives the reason as "Potential for cracked luer hubs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0324-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-15
Posted: 2018-01-09
Terminated: 2019-11-04
Recalling firm: Cordis US Corp.
Product: 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.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Potential for cracked luer hubs
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 511
Distribution: 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.
Product codes and lots: GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and 20705032066317 SF10100MB 41058.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0324-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0324-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-09

Product code FGE

K121125Class IIFlexstent Biliary Self-Expanding Stent SystemFlexible Stenting Solutions, Inc. / cleared 2012-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)