{
  "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": "38466",
      "product_res_number": "Z-0802-05",
      "event_date_initiated": "2005-01-25",
      "event_date_posted": "2005-05-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "31539",
      "product_code": "LWS",
      "pma_numbers": [
        "P970024"
      ],
      "product_description": "Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies.  The device also includes a programmable Hot Can electrode and bradycardia pacing support.",
      "code_info": "BE650129, BE650026 and BE650027.  OUS:  BE650038 and BE650002",
      "firm_fei_number": "2182863",
      "recalling_firm": "ela Medical Llc",
      "address_1": "2950 Xenium Ln N Ste 120 2950 Xenium Ln N",
      "address_2": "Ste 120",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55441-2623",
      "additional_info_contact": "Christina Doty\n763-519-9411",
      "reason_for_recall": "A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.",
      "root_cause_description": "Other",
      "action": "Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.",
      "product_quantity": "3 in US and 2 OUS",
      "distribution_pattern": "AZ, CA, GA, IL, IN, KY,  MA, MD, MI, MN, NC, NJ,  OH, PA and to UK, Italy, Germany and Argentina.",
      "openfda": {
        "pma_number": [
          "P930035",
          "P110042",
          "P890061",
          "P980023",
          "P940024",
          "P980016",
          "P010012",
          "P880006",
          "P960040",
          "P950022",
          "P050023",
          "P910073",
          "P900061",
          "P970024",
          "P030054",
          "P970013",
          "P940008",
          "P920015",
          "P980049",
          "P830060",
          "P220012",
          "P980050",
          "P030035",
          "P910023",
          "P010031",
          "P910077",
          "P880086"
        ],
        "registration_number": [
          "3018094310",
          "3014461810",
          "3004105270",
          "2649622",
          "3013500228",
          "2022502",
          "2183787",
          "3004961578",
          "1828132",
          "9614453",
          "1000121056",
          "9610139",
          "3010288227",
          "1028232",
          "1000165971",
          "3012552532",
          "3013288201",
          "3004593495",
          "3003120897",
          "3005334138",
          "3013674629",
          "2182208",
          "3008988055",
          "3008159616",
          "2030624",
          "3003932293",
          "3015453963",
          "3002806603",
          "3011120183",
          "2183744",
          "3010273872",
          "2124215",
          "3015544746",
          "3002807314",
          "2133641",
          "3009380063",
          "3003276151",
          "2032521",
          "3002807561",
          "1225687",
          "2017865",
          "9616693",
          "3013596024",
          "3006705815",
          "3033257494",
          "2011171",
          "1423662",
          "3008494315",
          "2135338",
          "2648729",
          "3008973940",
          "3004209178"
        ],
        "fei_number": [
          "3018094310",
          "3014461810",
          "3004105270",
          "3000203466",
          "2649622",
          "3013500228",
          "2022502",
          "2183787",
          "3004961578",
          "1828132",
          "1000121056",
          "3010288227",
          "1028232",
          "3002807576",
          "3003574398",
          "1000165971",
          "3012552532",
          "3013288201",
          "3008377825",
          "3004593495",
          "3000215273",
          "3003120897",
          "3005334138",
          "3013674629",
          "2182208",
          "3002618605",
          "3008159616",
          "3008988055",
          "3003932293",
          "3000206435",
          "3015453963",
          "3002806603",
          "3011120183",
          "2183744",
          "3010273872",
          "3004369318",
          "2124215",
          "3001451463",
          "3015544746",
          "3002807314",
          "3005700659",
          "3009380063",
          "3003276151",
          "3002807561",
          "2017865",
          "3013596024",
          "3006705815",
          "3033257494",
          "2011171",
          "3002806500",
          "2648729",
          "3008973940"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}