{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Dublin",
      "address_1": "7000 Cardinal Pl",
      "reason_for_recall": "Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU.  The correct classification is \"MRI Conditional\" not \"MRI Safe\".",
      "address_2": "",
      "product_quantity": "267,247 units total (262,641 OUS, 4,606 US)",
      "code_info": "All Lot Codes.  Affected SKUs:  N1020ABR, N1020BBR, N1020TBR, N1040ABR, N1040BBR, N1040EBR, N1040TBR, N1060ABR, N1060BBR, N1060EBR, N1060TBR, N1080ABR, N1080BBR, N1080EBR, N1080TBR, N6120BV, N620ABR, N620BBR, N620TBR, N640ABR, N640BBR, N640TBR, N660ABR, N660BBR, N660TBR, N680ABR, N680BBR, N680TBR, N7120BV, N720ABR, N720BBR, N720TBR, N740ABR, N740BBR, N740TBR, N760ABR, N760BBR, N760TBR, N780ABR, N780BBR, N780TBR, N8120BV, N820ABR, N820BBR, N820TBR, N840ABR, N840BBR, N840EBR, N840TBR, N860ABR,   N860BBR, N860EBR, N860TBR, N880ABR, N880BBR, N880EBR, N880TBR, N920ABR, N920BBR, N920TBR, N940ABR, N940BBR, N940TBR, N960ABR, N960BBR, N960TBR, N980ABR, N980BBR, N980TBR.",
      "center_classification_date": "20191220",
      "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.",
      "state": "OH",
      "product_description": "S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System.     The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system.  The stent is laser cut from a solid nitinol tube into a fine mesh ( Z  Configuration) design.  The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery.  Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery.  Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent.  The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system.  The stent is laser cut from a solid nitinol tube into a fine mesh ( Z  Configuration) design.  The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery.  Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery.  Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent.  The stent is equipped with 12 tantalum markers, 6 at each end, to increase the visibility of the stent under fluoroscopic imaging.  The SMART Control stent system is designed to be delivered through an appropriately sized catheter sheath introducer.",
      "report_date": "20200101",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cardinal Health Inc.",
      "recall_number": "Z-0728-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84228",
      "more_code_info": "",
      "recall_initiation_date": "20191114",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}