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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 120 cm Length)

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 Class 2 Device Recall FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 120 cm Length)see related information
Date Initiated by FirmApril 23, 2013
Date PostedJune 06, 2013
Recall Status1 Terminated 3 on June 27, 2014
Recall NumberZ-1509-2013
Recall Event ID 65182
510(K)NumberK112522 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductFLEXSTENT 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactIvenette Guzman
786-313-2000
Manufacturer 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.
FDA Determined
Cause 2		Package design/selection
ActionCordis 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 Commerce1357 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FGE
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