FLEXSTENT Biliary Self-Expanding Stent System — Class II medical device recall Z-1509-2013
Terminated recall by Cordis Corporation, reported 2013-06-12, distributed nationwide. Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degr
| Recall number | Z-1509-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2013-04-23 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, IT, NL, NZ |
| Quantity | 1,357 units |
| Model numbers | FLX-50030-B2, FLX-50040-B2, FLX-50060-B2, FLX-50080-B2, FLX-50100-B2, FLX-50120-B2, FLX-60030-B2, FLX-60040-B2, FLX-60060-B2, FLX-60080-B2, FLX-60100-B2, FLX-60120-B2, FLX-60150-B2, FLX-70030-B2, FLX-70040-B2, FLX-70060-B2, FLX-70080-B2, FLX-70100-B2, FLX-70120-B2, FLX-70150-B2, FLX-80030-B2, FLX-80040-B2, FLX-80060-B2, FLX-80080-B2, FLX-80100-B2 and 2 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1509-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.