{
  "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,
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  },
  "results": [
    {
      "cfres_id": "65385",
      "product_res_number": "Z-0069-2008",
      "event_date_initiated": "2007-10-15",
      "event_date_posted": "2007-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-21",
      "res_event_number": "45403",
      "product_code": "LWS",
      "pma_numbers": [
        "P920015"
      ],
      "product_description": "Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes.   Sterile.  This lead is designed for pacing, sensing, cardioversion and defibrillation therapies.    Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN  55432-5604 USA.",
      "code_info": "all codes",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Managment",
      "address_1": "7000 Central Ave Ne",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "additional_info_contact": "Medtronic Patient Services\n800-5515544 Ext. 41835",
      "reason_for_recall": "Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of",
      "root_cause_description": "Device Design",
      "action": "A press release was issued by Medtronic on 10/15/2007.  An FDA Statement was also issued on 10/15/2007.  An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians.  The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic.  This letter describes background information, performance and recommendations.  Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads  except in unusual individual patient circumstances.  An Important Patient Information letter was addressed to Medtronic Heart Device Patients.  Both letters can be found on Medtronic's website at www.medtronic.com/fidelis.  Return of product will be achieved with the assistance of Medtronic Representatives.",
      "product_quantity": "235,000 for all models",
      "distribution_pattern": "Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.",
      "openfda": {
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          "P880086",
          "P880006",
          "P010012",
          "P830060",
          "P220012",
          "P010031",
          "P980023",
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          "P940008",
          "P980049",
          "P950022",
          "P030054",
          "P900061",
          "P910077",
          "P970013",
          "P960040"
        ],
        "registration_number": [
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        "fei_number": [
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          "3000203466",
          "3000206435",
          "3001451463",
          "3012552532",
          "1028232"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}