{
  "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
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  },
  "results": [
    {
      "cfres_id": "170375",
      "product_res_number": "Z-0809-2019",
      "event_date_initiated": "2019-01-17",
      "event_date_posted": "2019-02-14",
      "recall_status": "Open, Classified",
      "res_event_number": "81945",
      "product_code": "NVZ",
      "pma_numbers": [
        "P980035"
      ],
      "product_description": "Medtronic implantable pulse generator:  SENSIA, Dual chamber pacemaker (DDD): \n(a) Model Number SED01\n(b) Model Number SEDR01\n(c) Model Number SEDRL1",
      "code_info": "SENSIA, Dual chamber pacemaker (DDD):  (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "city": "Mounds View",
      "state": "MN",
      "postal_code": "55112-4391",
      "additional_info_contact": "Technical Services\n800-505-4636",
      "reason_for_recall": "A  subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality",
      "root_cause_description": "Component design/selection",
      "action": "In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand deliver an FCA Notification Letter to consignees including implanting and follow-up physicians. In consultation with an Independent Physician Quality Panel (IPQP), patient management recommendations were provided with the FCA Notification letter to ensure patient safety.\n\nMedtronic Field Representatives will hand deliver an additional Supplemental Letter with the Urgent Medical Device Recall letter to a subset of physicians with patients whose device has shown evidence of a pacing pause that is potentially related to this circuit error. Consignees will be asked to return all unused and unopened affected product to Medtronic.",
      "product_quantity": "59232 units",
      "distribution_pattern": "Wordlwide",
      "openfda": {
        "pma_number": [
          "P910023",
          "P990001",
          "P880038",
          "P950029",
          "P960013",
          "P010031",
          "P880086",
          "P950037",
          "P890003",
          "P830045",
          "P980035",
          "P880006",
          "P900070",
          "P970012",
          "P010015",
          "P930022"
        ],
        "registration_number": [
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          "3008159616",
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          "2032521",
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        ],
        "fei_number": [
          "3005700659",
          "3015453963",
          "3003574398",
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          "3002807111",
          "3011120183",
          "1000165971"
        ],
        "device_name": "Pulse Generator, Permanent, Implantable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}