{
  "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": [
    {
      "status": "Terminated",
      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84152",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide including Washington D.C. and Puerto Rico.  OUS to include Canada.",
      "recall_number": "Z-0580-2020",
      "product_description": "Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS  3.0mm x 24mm.  The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.",
      "product_quantity": "14,145 devices total",
      "reason_for_recall": "Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.",
      "recall_initiation_date": "20191024",
      "center_classification_date": "20191126",
      "termination_date": "20230320",
      "report_date": "20191204",
      "code_info": "Lot / GTIN Number / Use By:  24077337 / 8714729843443 / 2019-07-17.",
      "more_code_info": ""
    }
  ]
}