{
  "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": "2026-06-17",
    "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": "103 units",
      "code_info": "Product UPN/GTIN:  00721902791130  Serial Numbers:  PNR100502Q  PNR100510Q  PNR100522Q  PNR100535Q    Product UPN/GTIN:  00721902791147  Serial Numbers:  PNR100129Q  PNR100130Q  PNR100131Q  PNR100134Q  PNR100135Q  PNR100138Q  PNR100139Q  PNR100141Q  PNR100143Q  PNR100144Q  PNR100146Q  PNR100147Q  PNR100150Q  PNR100151Q  PNR100153Q  PNR100154Q  PNR100155Q  PNR100156Q  PNR100157Q  PNR100160Q  PNR100161Q  PNR100162Q  PNR100163Q  PNR100164Q  PNR100165Q  PNR100166Q  PNR100167Q  PNR100168Q  PNR100169Q  PNR100174Q  PNR100175Q  PNR100176Q  PNR100178Q  PNR100182Q  PNR100183Q  PNR100184Q  PNR100185Q  PNR100188Q  PNR100191Q  PNR100192Q  PNR100193Q  PNR100195Q  PNR100196Q  PNR100197Q  PNR100198Q  PNR100200Q  PNR100204Q  PNR100208Q  PNR100210Q  PNR100211Q  PNR100212Q  PNR100213Q  PNR100215Q  PNR100216Q  PNR100217Q  PNR100218Q  PNR100219Q  PNR100220Q  PNR100221Q  PNR100222Q  PNR100223Q  PNR100224Q  PNR100225Q  PNR100226Q  PNR100227Q  PNR100228Q  PNR100229Q  PNR100230Q  PNR100233Q  PNR100234Q  PNR100236Q  PNR100237Q  PNR100238Q  PNR100239Q  PNR100241Q  PNR100242Q  PNR100243Q  PNR100244Q  PNR100245Q  PNR100247Q  PNR100249Q  PNR100252Q  PNR100253Q  PNR100254Q  PNR100256Q  PNR100259Q  PNR100261Q  PNR100262Q  PNR100263Q  PNR100264Q  PNR100266Q  PNR100267Q  PNR100270Q    Product UPN/GTIN: 00885074299907  Serial Numbers:  PNR419863H    Product UPN/GTIN: 00885074300207  Serial Numbers:  PNR406072H  PNR406348H  PNR406416H  PNR407438H  PNR407439H",
      "center_classification_date": "20180710",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "state": "MN",
      "product_description": "Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG    Product Usage:  The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. 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-2416-2018",
      "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"
    }
  ]
}