{
  "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": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "96009",
      "product_res_number": "Z-0857-2011",
      "event_date_initiated": "2010-10-19",
      "event_date_posted": "2011-01-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-27",
      "res_event_number": "57179",
      "product_code": "HGC",
      "k_numbers": [
        "K012985",
        "K031168"
      ],
      "product_description": "Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.",
      "code_info": "Material \tProduct Description \tCatalog # \tBatch Numbers Expiry Date   M0034751030 \tMatrix2¿ 3D-Omega Standard \t475103 \t13097570 \tOct2012  \tCoils 1 Omm x 30cm \t\t\t M0034753060 \tMatrix2¿ 3D-Omega Standard \t475306 \t13204826 \tDec2012  \tCoils 3mm x 6cm \t\t\t M0034754060 \tMatrix2¿ 3D-Omega Standard \t475406 \t13199749 \tDec2012  \tCoils 4mm x 6cm \t\t\t M0034755080 \tMatrix2¿ 3D-Omega Standard \t475508 \t13204829 \tDec2012  \tCoils 5mm x 8cm \t\t\t M0034755100 \tMatrix2¿ 3D-Omega Standard \t475510 \t13097571 \tOct2012                        Coils 5mm x 10cm",
      "firm_fei_number": "2939204",
      "recalling_firm": "Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538",
      "address_1": "47900 Bayside Pkwy",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6515",
      "additional_info_contact": "Robert Ware\n510-624-2544",
      "reason_for_recall": "The product appears to have premature degradation of the PGLA coating on the Matrix Coil.",
      "root_cause_description": "Process control",
      "action": "US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.",
      "product_quantity": "77,364 total units",
      "distribution_pattern": "Worldwide distribution.  USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau,  Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.",
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        "device_name": "Clamp, Uterine",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4520",
        "device_class": "1",
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