{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mounds View",
      "address_1": "8200 Coral Sea St Ne",
      "reason_for_recall": "Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage.  Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert.  Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.",
      "address_2": "",
      "product_quantity": "3 units",
      "code_info": "Product UPN/GTIN:  00885074300245  Serial Numbers:  PNT402938H  PNT413911H  PNT413995H",
      "center_classification_date": "20180710",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "state": "MN",
      "product_description": "Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC    Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.",
      "report_date": "20180718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "recall_number": "Z-2418-2018",
      "initial_firm_notification": "Visit",
      "product_type": "Devices",
      "event_id": "80379",
      "termination_date": "20210616",
      "more_code_info": "",
      "recall_initiation_date": "20180621",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}