{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mounds View",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81945",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "address_2": "N/A",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Wordlwide",
      "recall_number": "Z-0809-2019",
      "product_description": "Medtronic implantable pulse generator:  SENSIA, Dual chamber pacemaker (DDD):   (a) Model Number SED01  (b) Model Number SEDR01  (c) Model Number SEDRL1",
      "product_quantity": "59232 units",
      "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",
      "recall_initiation_date": "20190117",
      "center_classification_date": "20190214",
      "report_date": "20190220",
      "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"
    }
  ]
}