{
  "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": "Terminated",
      "city": "Draper",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81924",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "12050 S Lone Peak Pkwy",
      "address_2": "N/A",
      "postal_code": "84020-9414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "WorldwideDistribution",
      "recall_number": "Z-0835-2019",
      "product_description": "Edward Lifesciences, Edwards Commander Delivery System:  Model Number\tUDI Number  9600LDS20A (US)\t00690103193930  9600LDS20J\t00690103194852  9600LDS23A (US)\t00690103193947  9600LDS23J\t00690103194869  9600LDS26A (US)\t00690103193954  9600LDS26J\t00690103194876  9600LDS29A (US)\t00690103193961  9600LDS29J\t00690103194883  9610TF20\t00690103192995  9610TF23\t00690103190458  9610TF26\t00690103190465  9610TF29\t00690103193008      Product Usage:  The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis",
      "product_quantity": "159,448 units",
      "reason_for_recall": "This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.",
      "recall_initiation_date": "20190122",
      "center_classification_date": "20190214",
      "termination_date": "20190326",
      "report_date": "20190220",
      "code_info": "(ALL LOTS  Model Number UDI Number  9600LDS20A (US) 00690103193930  9600LDS20J 00690103194852  9600LDS23A (US) 00690103193947  9600LDS23J 00690103194869  9600LDS26A (US) 00690103193954  9600LDS26J 00690103194876  9600LDS29A (US) 00690103193961  9600LDS29J 00690103194883  9610TF20 00690103192995  9610TF23 00690103190458  9610TF26 00690103190465  9610TF29 00690103193008"
    }
  ]
}