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Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the pallia...

FDA Device Recall #Z-0324-2018 — Class II — November 15, 2017

Recall Summary

Recall Number Z-0324-2018
Classification Class II — Moderate risk
Date Initiated November 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cordis Corporation
Location Miami Lakes, FL
Product Type Devices
Quantity 511

Product Description

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.

Reason for Recall

Potential for cracked luer hubs

Distribution Pattern

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.

Lot / Code Information

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.

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.

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