{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "84609",
      "product_res_number": "Z-0180-2010",
      "event_date_initiated": "2009-08-07",
      "event_date_posted": "2009-11-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-04",
      "res_event_number": "53083",
      "product_code": "LWS",
      "pma_numbers": [
        "P910077S092"
      ],
      "product_description": "Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN  55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely.  \n\nThe LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.",
      "code_info": "SERIAL NUMBERS:  029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519,  603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067,  055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895,  602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034,  063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973,  063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499,  039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812  024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific CRM Corp",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "651-582-4000",
      "reason_for_recall": "The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup.  The issue has been resolved.  If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers.  It",
      "root_cause_description": "Software design",
      "action": "Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected.  Notifications via phone calls to additional patients affected began on August 17, 2009.  \n\nDirect questions about the recall to the LATITUDE Customer Service by calling\n1-651-582-4000.",
      "product_quantity": "97",
      "distribution_pattern": "Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.",
      "openfda": {
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          "P940008",
          "P980049",
          "P950022",
          "P030054",
          "P900061",
          "P910077",
          "P970013",
          "P960040"
        ],
        "registration_number": [
          "1828132",
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        "fei_number": [
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          "3013288201",
          "3000203466",
          "3000206435",
          "3001451463",
          "3012552532",
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        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}