{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "37422",
      "product_res_number": "Z-0639-05",
      "event_date_initiated": "2005-02-14",
      "event_date_posted": "2005-03-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-08-22",
      "res_event_number": "31230",
      "product_code": "MTD",
      "k_numbers": [
        "K000277",
        "K003782",
        "K021232",
        "K983171",
        "K992777"
      ],
      "product_description": "Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075",
      "code_info": "Model numbers 8031, 8038, 8048, 8060, 8075.  510(k) numbers K983171, K992777, K000277, K021232, K003782.  Product Code DXQ.  Product UPN numbers: Domestic:  Constellation 31 mm/2mm:  M004 US8031 0, M004 US8031 L0, M004 US8031 M0.  38mm/3mm:  M004US8038 0, 4004 US8038 L0, M004 US8038P0.  48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0.  60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0.  75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0.    Outside of US product:  Constellation 31 mm/2mm:  M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0.  38mm/3mm:  M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0.  48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0.  60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0.  75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.",
      "firm_fei_number": "3001236349",
      "recalling_firm": "Boston Scientific",
      "address_1": "2710 Orchard Pkwy",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95134-2012",
      "additional_info_contact": "408-895-3500",
      "reason_for_recall": "The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.",
      "root_cause_description": "Other",
      "action": "All consignees were notified via customer letters sent out on 02/14/2005.  Distributors outside the US will be formally notified via the firm's recall procedures.",
      "product_quantity": "6694 units were distributed.",
      "distribution_pattern": "This product was distributed to 521 accounts worldwide.",
      "openfda": {
        "k_number": [
          "K233433",
          "K982540",
          "K992777",
          "K123837",
          "K130827",
          "K142182",
          "K241372",
          "K120425",
          "K261012",
          "K253205",
          "K021232",
          "K170819",
          "K230253",
          "K172393",
          "K201341",
          "K223666",
          "K983171",
          "K231312",
          "K193237",
          "K200212",
          "K012926",
          "K140733",
          "K201750",
          "K990795",
          "K003782",
          "K121006",
          "K163709",
          "K000277",
          "K983456",
          "K153093",
          "K211438",
          "K210766",
          "K201806",
          "K050217"
        ],
        "registration_number": [
          "1650907",
          "3019807891",
          "3013403214",
          "1721686",
          "2183787",
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          "3008452825",
          "2182269",
          "3005334138",
          "3012179728",
          "1721676",
          "3016678045",
          "2184149",
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          "2183744",
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          "2032112",
          "3014279513",
          "3016986313",
          "3008093809",
          "3009888344",
          "2124215",
          "3017060084"
        ],
        "fei_number": [
          "3019807891",
          "3013403214",
          "1721686",
          "2183787",
          "1928237",
          "3011276773",
          "3038966633",
          "3013581838",
          "3013627970",
          "3002681132",
          "3008452825",
          "2182269",
          "3005334138",
          "3003076831",
          "3012179728",
          "1721676",
          "3016678045",
          "3003248396",
          "3013300026",
          "2183744",
          "3010273872",
          "3011610434",
          "3004450679",
          "3014279513",
          "1000519796",
          "1000139754",
          "3016986313",
          "3008093809",
          "3009888344",
          "2124215",
          "3017060084"
        ],
        "device_name": "Catheter, Intracardiac Mapping, High-Density Array",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}