{
  "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": "160480",
      "product_res_number": "Z-0362-2018",
      "event_date_initiated": "2017-12-07",
      "event_date_created": "2018-01-15",
      "recall_status": "Open, Classified",
      "res_event_number": "78787",
      "product_code": "LWP",
      "product_description": "ALTRUA 2 SR Pacemaker",
      "code_info": "Model S701",
      "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",
      "additional_info_contact": "Technical Services\n800-227-3422",
      "reason_for_recall": "Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).",
      "root_cause_description": "Device Design",
      "action": "On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:\nDecember 2017\nDear Doctor,\nBoston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude\n(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).\nBoston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in\nMarch 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.\nRoot Cause Investigation\nThe MV sensor in Boston Scientific pacemakers can be used for RightRate\" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan\"1. When the RA/RV pacing leads and lead terminal connections are operating as\nintended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has\nthe potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or\nRV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.\nEngineering analysis and",
      "distribution_pattern": "AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico\nWorldwide",
      "openfda": {
        "pma_number": [
          "P030035",
          "P830026",
          "P950029",
          "P930022",
          "P830007",
          "N970003",
          "P980035",
          "P940031",
          "P890003",
          "P850051",
          "P970012",
          "P010015",
          "P780009",
          "P820023",
          "P820018",
          "P910023",
          "P990001",
          "P860027",
          "P880086",
          "P140033",
          "P010012",
          "P880006",
          "P840068",
          "P090013",
          "P800019",
          "P900022",
          "P840014",
          "P830045",
          "P820076",
          "P150012",
          "P820014",
          "P950037",
          "P030054",
          "P970013",
          "P820003",
          "P960040"
        ],
        "registration_number": [
          "3003120897",
          "3005334138",
          "9616693",
          "1721676",
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        ],
        "fei_number": [
          "3003120897",
          "3005334138",
          "1721676",
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          "2124215",
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          "3008973940",
          "3002618605",
          "3013288201",
          "3000203466",
          "3012552532",
          "1028232"
        ],
        "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}