{
  "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": "142360",
      "product_res_number": "Z-0620-2016",
      "event_date_initiated": "2015-12-10",
      "event_date_posted": "2016-01-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-03-08",
      "res_event_number": "72855",
      "product_code": "LWP",
      "product_description": "Boston Scientific, MRI PROPONENT\" SR , REF L210 Pacemaker.\n\nThese devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary",
      "code_info": "Serial numbers 702961, 702963, 705644, 705666, and 705947.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "Boston Scientific Representative\n800-227-3422",
      "reason_for_recall": "The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.",
      "root_cause_description": "Labeling mix-ups",
      "action": "The firm, Boston Scientific, sent a \"Medical Device Retrieval\" letter dated December 2015 to its Consignees on 12/10/2015.  The letter described the problem, product involved in the recall and actions to be taken. The consignees were instructed to immediately segregate the product to ensure that it will not be used, obtain an IAN (inventory authorization number) from Boston Scientific's Logistics Department by email at randall.peterfeso@bsci.com; return it back to Boston Scientific-Clonmel Cashel Rd., Clonmel Co Tipperary Ireland. \n\nIf you have any questions about this retrieval contact your local Boston Scientific representative or a Technical Services representatives at 1-800-CARDIAC (227-3422) tech.services@bsci.com or randall.peterfeso@bsci.com.",
      "product_quantity": "5",
      "distribution_pattern": "International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.",
      "openfda": {
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          "P950029",
          "P820014",
          "P880086",
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          "P010012",
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          "P030054",
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          "P960040",
          "P780009",
          "P900022",
          "P860027",
          "P840068",
          "P010015"
        ],
        "registration_number": [
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          "1450662",
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        ],
        "fei_number": [
          "3005700659",
          "3003574398",
          "3002618605",
          "3008159616",
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          "3002806603",
          "1450662",
          "3033257494",
          "3009380063",
          "3008377825",
          "1000165971"
        ],
        "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}