{
  "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": "183949",
      "product_res_number": "Z-0319-2021",
      "event_date_initiated": "2020-09-22",
      "event_date_created": "2020-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-04",
      "res_event_number": "86534",
      "product_code": "LWS",
      "pma_numbers": [
        "P910077S178"
      ],
      "product_description": "Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application",
      "code_info": "Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N Bldg 3",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "reason_for_recall": "There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.",
      "root_cause_description": "Software design",
      "action": "Boston Scientific sales representatives will hand-deliver a removal letter to all customer consignees with one of the eight affected Model 3300 LATITUDE programmer.  BSC sales representatives will maintain control of these devices.\n\nIn order to continue to provide the benefits that this software support application\nprovides for those patients implanted with an ALTRUA/INSIGNIA I pacemaker,\nBSC sales representatives will continue to use Model 3300 LATITUDE programmers\ninstalled with the Model 3892 v1.04 ALTRUA / INSIGNIA I / NEXUS I Software\nSupport Application in the field. The risks associated with this unintended behavior\ncan be avoided when specific remedial actions are adhered to. These remedial actions will be adhered to until a software correction is approved and installed on these programmers.\n\nBSC will confirm via email from sales representatives that 100% of the removal\nletters were delivered.\n\nBSC will post the removal letter on the BSC website within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html.",
      "product_quantity": "8 devices",
      "distribution_pattern": "Distributed in US - AR, FL, IL, and TX",
      "openfda": {
        "pma_number": [
          "P920015",
          "P030035",
          "P930035",
          "P110042",
          "P980016",
          "P970024",
          "P940024",
          "P890061",
          "P910073",
          "P910023",
          "P980050",
          "P880086",
          "P880006",
          "P010012",
          "P830060",
          "P220012",
          "P010031",
          "P980023",
          "P050023",
          "P940008",
          "P980049",
          "P950022",
          "P030054",
          "P900061",
          "P910077",
          "P970013",
          "P960040"
        ],
        "registration_number": [
          "1828132",
          "3014461810",
          "3003120897",
          "3002807314",
          "1225687",
          "3005334138",
          "3008988055",
          "9616693",
          "3018094310",
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          "3010273872",
          "2124215",
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          "3010288227",
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          "3003276151",
          "3006705815",
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        "fei_number": [
          "1828132",
          "3014461810",
          "3003120897",
          "3002807314",
          "3005334138",
          "3008988055",
          "3018094310",
          "2022502",
          "2011171",
          "1000121056",
          "3010273872",
          "2124215",
          "3033257494",
          "1000165971",
          "3005700659",
          "3003574398",
          "3002806603",
          "3004961578",
          "3009380063",
          "3002807576",
          "3013674629",
          "3010288227",
          "3008159616",
          "3015453963",
          "3004105270",
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          "3006705815",
          "3000215273",
          "3013596024",
          "2183744",
          "3015544746",
          "2649622",
          "2183787",
          "2182208",
          "3008377825",
          "3002806500",
          "3013500228",
          "3003932293",
          "2648729",
          "3004593495",
          "2017865",
          "3008973940",
          "3002807561",
          "3002618605",
          "3011120183",
          "3013288201",
          "3000203466",
          "3000206435",
          "3001451463",
          "3012552532",
          "1028232"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}