{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "91735",
      "product_res_number": "Z-0482-2011",
      "event_date_initiated": "2010-03-01",
      "event_date_posted": "2010-11-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-11-26",
      "res_event_number": "55760",
      "product_code": "NJE",
      "product_description": "Neuroform 3 Microdelivery Stent System; Distributed and manufactured by:  Boston Scientific Corporation, Fremont, CA",
      "code_info": "Model number: M003E3400300; expiration date October 2012   UPN\t                     Batch              UPN                                Batch  M003E3300150\t12907487\t   M003E3400150\t12954887 M003E3300200\t12915007\t   M003E3400200\t12954888 M003E3350200\t12915008\t   M003E3400300\t12958309 M003E3450200\t12915009\t   M003SNF330200\t12965212 M003SNF330200\t12915010\t   M003SNF335200\t12965215 M003SNF340200\t12915011\t   M003SNF335300\t12968779 M003SNF345200\t12915013\t   M003SNF335200\t12969012 M003E3300300\t12922996\t    M003SNF345300\t12969013 M003E3350200\t12923544\t    M003E3450150\t12973549 M003E3300200\t12925243\t    M003E3300200\t12976185 M003E3400200\t12925245\t    M003E3350300\t12976374 M003E3400300\t12925248\t    M003E3450200\t12976378 M003E3450300\t12925252\t    M003SNF330200\t12978991 M003SNF325200\t12929490\t    M003SNF335200\t12969012 M003SNF30150\t12929491\t    M003SNF340200\t12979305 M003SNF335200\t12929492\t    M003E3300200\t12983886 M003SNF340200\t12929494\t    M003SNF345300\t12982462 M003SNF330150\t12929491\t    M003E3400150\t12990085 M003SNF345200\t12929492\t    M003E3400200\t12990088 M003SNF340200\t12929494\t    M003E34000300\t12990098 M003SNF340300\t12929495\t    M003E3450200          12990124 M003SNF325200\t12932459\t    M003SNF330200\t12993187 M003SNF345200\t12932945\t     M003SNF335150\t12993189 M003SNF345300\t12932946\t     M003SNF340200\t12993190 M003E3350200\t12936662\t     M003SNF340300\t12993193 M003E3400200\t12936665\t     M003E3350200\t12996254 M003E3450150\t12936668\t     M003SNF34150\t12996255 M003E3450200\t12940485\t      M003SNF335200\t12996436 M003E3450300\t12940950\t      M003E3400150\t13010766 M003SNF335150\t12943248\t      M003E3450300\t13010770 M003SNF335200\t12943594\t      M003SNF325200\t13010771 M003SNF340200\t12943598\t      M003SNF330150\t13010772 M003E3250200\t12947325\t      M003E3350200\t13013322 M003E3300200\t12947486\t      M003E3350300\t13013323 M003E3450300\t12947611\t      M003SNF335200\t13017103 M003E3350200\t12950991\t      M003SNF335200\t12969012 M003SNF325150\t12950988         M003SNF345300\t12950989",
      "firm_fei_number": "2939204",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "47900 Bayside Pkwy",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6515",
      "additional_info_contact": "510-624-2544",
      "reason_for_recall": "The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used.",
      "root_cause_description": "Process control",
      "action": "Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form.\nCustomers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall.",
      "product_quantity": "638 units",
      "distribution_pattern": "Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary,  India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.",
      "openfda": {
        "registration_number": [
          "3002807314",
          "9681260",
          "1721676",
          "2126666",
          "2011171",
          "1226348",
          "3008114965",
          "3007628272",
          "1000121056",
          "3008853977",
          "3008881809",
          "2029214",
          "2134265",
          "2124215",
          "3004859241",
          "3008837339",
          "1220477"
        ],
        "fei_number": [
          "3002947440",
          "3002807314",
          "3002806565",
          "1721676",
          "1000220862",
          "2126666",
          "2011171",
          "3008114965",
          "3007628272",
          "1000121056",
          "3008853977",
          "3008881809",
          "2124215",
          "3002095335",
          "3004859241",
          "3008837339",
          "1220477"
        ],
        "device_name": "Intracranial Neurovascular Stent",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f"
      }
    }
  ]
}