FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES ...
FDA Device Recall #Z-1509-2013 — Class II — April 23, 2013
Recall Summary
| Recall Number | Z-1509-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 23, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cordis Corporation |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 1357 units |
Product Description
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.
Distribution Pattern
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
Lot / 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
Other Recalls from Cordis Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ F... | Oct 1, 2021 |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.