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Use caution Medical device recall · FDA · Published November 15, 2017

Cordis S.M.A.R.T. Flex Biliary Stent System Recall: Cracked Luer Hubs Risk

Cordis recalls S.M.A.R.T. Flex Biliary Stent Systems with potential cracked luer hubs that could cause leaks or dislodgement during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0324-2018Medical deviceCordis ›
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Contact the company

Recalling firmCordis Corporation14201 NW 60th Ave · Miami Lakes, FL 33014-2802
✎ GovInfoNow plain-language explainer

Cordis is recalling certain S.M.A.R.T. Flex Biliary Stent Systems due to a risk of cracked luer hubs. This could lead to leaks or dislodgement during medical procedures, potentially causing complications for patients needing biliary stent treatments. Read more at govinfonow.com/recall/72536-cordis-s-m-a-r-t-flex-biliary-stent-system.

Source Summary by GovInfoNow · govinfonow.com/recall/72536-cordis-s-m-a-r-t-flex-biliary-stent-system · Updated September 1, 2026 · FDA enforcement record: FDA #Z-0324-2018

Cite this page

“Cordis S.M.A.R.T. Flex Biliary Stent System Recall: Cracked Luer Hubs Risk.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72536-cordis-s-m-a-r-t-flex-biliary-stent-system. Based on FDA recall #Z-0324-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0324-2018%22&limit=1).

The FDA announced on November 15, 2017, that Cordis Corporation voluntarily recalled the Cordis S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs. The recall affects 511 units distributed worldwide and in the United States.

How to tell if you have it

  • Brand: Cordis
  • Product: Cordis S.M.A.R.T. Flex Biliary Stent System
  • GTIN 20705032065600, Catalog SF05100MB, Lot Numbers 41316 and 41352
  • GTIN 20705032065648, Catalog SF06100MB, Lot Numbers 41318 and 41353
  • GTIN 20705032065723, Catalog SF06120MB, Lot Number 40997 and 41354
  • GTIN 20705032066034, Catalog SF06150MB, Lot Numbers 41198 and 41355
  • GTIN 20705032065747, Catalog SF07080MB, Lot Number 41319
  • GTIN 20705032065655, Catalog SF07100MB, Lot Numbers 40999 and 41199
  • GTIN 20705032065617, Catalog SF07150MB, Lot Numbers 41200 and 41356
  • GTIN 20705032065662, Catalog SF08100MB, Lot Number 41320
  • GTIN 20705032066348, Catalog SF08120MB, Lot Number 41056
  • GTIN 20705032066171, Catalog SF09030MB, Lot Number 41055
  • GTIN 20705032066164, Catalog SF09030SB, Lot Number 41203
  • GTIN 20705032066263, Catalog SF09060MB, Lot Numbers 41003 and 41359
  • GTIN 20705032065938, Catalog SF09060SB, Lot Number 41122
  • GTIN 20705032066096, Catalog SF09080MB, Lot Number 40998
  • GTIN 20705032066072, Catalog SF09080SB, Lot Numbers 41004 and 41202
  • GTIN 20705032065778, Catalog SF09100SB, Lot Numbers 40996 and 41124
  • GTIN 20705032065570, Catalog SF10040SB, Lot Number 41322
  • GTIN 20705032065945, Catalog SF10060SB, Lot Number 41002
  • GTIN 20705032066089, Catalog SF10080SB, Lot Number 41323
  • GTIN 20705032066317, Catalog SF10100MB, Lot Number 41058

The hazard

The recall is due to the potential for cracked luer hubs on the Cordis S.M.A.R.T. Flex Biliary Stent System. The device is indicated for use in the palliation of malignant strictures in the biliary tree.

Context

GovInfoNow's records show that Cordis Corporation has 9 other recalls on record since September 5, 2018. Other recent recalls of similar products include Boston Scientific: HOT AXIOS Stent System Recall Due to Deployment Issues (December 19, 2025), INSPIREMD CGuard Prime Carotid Stent System Recall: Deployment Complications Risk (May 1, 2026), and Microvention LVIS Stent Device Recall: Risk of Vessel Injury from Manufacturing Errors (April 6, 2026).

How to tell if you have this one

Check for the product model codes (SF05100MB, SF06100MB, etc.) and lot numbers (41316, 41352, etc.) listed in the recall notice. The product is sold under the Cordis S.M.A.R.T. Flex Biliary Stent System name.

  • Brand
    Cordis
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the model code and lot number on the product to see if it matches the recalled items listed in the notice.

  2. Contact Cordis

    Reach out to Cordis Corporation for assistance with the recall process if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 29 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Nov 15, 201712. FDA classified it Class II: Jan 9, 201823. Published in FDA’s Enforcement Report: Jan 17, 201834. FDA terminated the recall: Nov 4, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which model numbers are affected?

The affected model numbers include SF05100MB, SF06100MB, SF06120MB, SF06150MB, SF07080MB, SF07100MB, SF07150MB, SF08100MB, SF08120MB, SF09030MB, SF09030SB, SF09060MB, SF09060SB, SF09080MB, SF09080SB, SF09100SB, SF10040SB, SF10060SB, and SF10080SB.

How can I tell if I have the recalled product?

Check the model code and lot number on the product against the list provided in the recall notice.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0324-2018 (November 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0324-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 1, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA