{
  "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": "39931",
      "product_res_number": "Z-0907-05",
      "event_date_initiated": "2005-06-17",
      "event_date_posted": "2005-06-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-01-10",
      "res_event_number": "32380",
      "product_code": "NIK",
      "pma_numbers": [
        "P010012S002"
      ],
      "product_description": "CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).  Sterilized with gaseous ethylene oxide.  Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN  55112-5798.  USA.  Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.",
      "code_info": "RENEWAL (model H135) serial number range 100027 - 999983 includes CRT-Ds manufactured on or before August 26, 2004.  These ranges include all affected devices but may include some unaffected devices.",
      "firm_fei_number": "2124215",
      "recalling_firm": "Guidant Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "866-484-3268",
      "reason_for_recall": "Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.",
      "root_cause_description": "Other",
      "action": "Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices.  The letter gave indications of device failure and recommendations for patient visits.  A press release was also issued on 06/17/05.",
      "product_quantity": "16,000 (Approximately 11,900 remain implanted worldwide)",
      "distribution_pattern": "worldwide.  Including the United States and countries such as:  Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P050023",
          "P910023",
          "P030054",
          "P010031",
          "P060027",
          "P880086",
          "P000009",
          "P030035",
          "P880006",
          "P010012",
          "P970013"
        ],
        "registration_number": [
          "3015453963",
          "3008159616",
          "3018094310",
          "9616693",
          "3013288201",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "2124215",
          "3008494315",
          "9614453",
          "2648729",
          "1028232",
          "3013596024",
          "3012552532",
          "2133641",
          "3002806603",
          "3033257494",
          "2032521",
          "3009380063",
          "9610139",
          "3005941719",
          "1000165971"
        ],
        "fei_number": [
          "3015453963",
          "3003574398",
          "3002618605",
          "3008159616",
          "3018094310",
          "3013288201",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "2124215",
          "3002807576",
          "3000203466",
          "2648729",
          "1028232",
          "3013596024",
          "3012552532",
          "3002806500",
          "3002806603",
          "3033257494",
          "3009380063",
          "3008377825",
          "3002807111",
          "1000165971"
        ]
      }
    }
  ]
}