Z-1509-2013Class II

FLEXSTENT Biliary Self-Expanding Stent System

Name: Z-1509-2013 FLEXSTENT Biliary Self-Expanding Stent System
Creator: Cordis Corporation
Published: 2013-04-23
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2013-04-23 / Terminated / root cause: packaging

FDA source

Cordis Corporation began a recall of FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant... on 2013-04-23. FDA classified it as Class II and gives the reason as "Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1509-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-23
Posted: 2013-06-06
Terminated: 2014-06-27
Recalling firm: Cordis US Corp.
Product: FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product 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: Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.
Quantity in commerce: 1357 units
Distribution: Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
Product codes and lots: 27 Catalog Numbers FLX-50030-B2, FLX-60030-B2, FLX-70030-B2, FLX-80030-B2, FLX-50040-B2, FLX-60040-B2, FLX-70040-B2, FLX-80040-B2, FLX-50060-B2, FLX-60060-B2, FLX-70060-B2, FLX-80060-B2, FLX-50080-B2, FLX-60080-B2, FLX-70080-B2, FLX-80080-B2, FLX-50100-B2, FLX-60100-B2, FLX-70100-B2, FLX-80100-B2, FLX-50120-B2, FLX-60120-B2, FLX-70120-B2, FLX-80120-B2, FLX-60150-B2, FLX-70150-B2, FLX-80150-B2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1507-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1508-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1509-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1510-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1511-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code FGE

K112522Class IIFlexstent Biliary Self-Expanding Stent SystemFlexible Stenting Solutions, Inc. / cleared 2011-12-30

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)