{
  "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": "42341",
      "product_res_number": "Z-0891-06",
      "event_date_initiated": "2005-09-30",
      "event_date_posted": "2006-05-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-01-16",
      "res_event_number": "33716",
      "product_code": "NIK",
      "pma_numbers": [
        "P010012"
      ],
      "product_description": "CONTAK RENEWAL 4 CRT-D (model no. H190, H195,  H199).  Cardiac Resynchronization Therapy Defibrillator.  Sterilized with gaseous ethylene oxide.  Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN  55112-5798 USA.  CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.",
      "code_info": "Model H190, serial numbers:  310258, 310260, 310293, 310312, 310317, 310319, 310320, 310321, 310322, 310343,  310353, 310355, 310381, 310383, 310386, 310387, 310388,  310389, 310390.     Model H195, serial numbers:  350236, 350239, 350245,  350247, 350248, 350250, 350252, 350255, 350261, 350264,  350276, 350279, 350280, 350282, 350284, 350319, 350330,  350331, 350332, 350333, 350334, 350336, 350342, 350344,  350350, 350351, 350353, 350354, 350355, 350360, 350362,  350363, 350364, 350365, 350403, 350407, 350442, 350451,  350480, 350484, 350503, 350570, 350649.  Model H199, serial numbers:  320330, 320331, 320361, 320366, 320370, 320415, 320417, 320445.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Guidant Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5798",
      "reason_for_recall": "Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.",
      "root_cause_description": "Other",
      "action": "Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians.  The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which  they tried to induce the failure.  The results of the testing induced 2 battery weld post failures.  A projected rate of occurence was also given.  Patient management recommendations have not changed.",
      "product_quantity": "70",
      "distribution_pattern": "Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI).  OUS to include:  Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, United Kingdom.",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P050023",
          "P970013",
          "P000009",
          "P030035",
          "P910023",
          "P060027",
          "P010012",
          "P880006",
          "P010031",
          "P030054",
          "P880086"
        ],
        "registration_number": [
          "3018094310",
          "3013500228",
          "9614453",
          "9610139",
          "1028232",
          "1000165971",
          "3012552532",
          "3013288201",
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          "3005334138",
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          "3015453963",
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        ],
        "fei_number": [
          "3018094310",
          "3000203466",
          "3013500228",
          "1028232",
          "3003574398",
          "3002807576",
          "1000165971",
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          "3008377825",
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          "3002618605",
          "3008159616",
          "3015453963",
          "3002806603",
          "3002807111",
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        ]
      }
    }
  ]
}