{
  "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": "Palm Harbor",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75785",
      "recalling_firm": "Oscor, Inc.",
      "address_1": "3816 Desoto Blvd",
      "address_2": "N/A",
      "postal_code": "34683-1618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM",
      "recall_number": "Z-0814-2017",
      "product_description": "MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL  Catalog # 990061-120-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.",
      "product_quantity": "186",
      "reason_for_recall": "Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.",
      "recall_initiation_date": "20161005",
      "center_classification_date": "20161219",
      "termination_date": "20190726",
      "report_date": "20161228",
      "code_info": "Lot #'s: C1-08466 Exp. December 19, 2016, C1-09857 Exp. March 5, 2018, C1-10215 Exp. April 29, 2018, and C1-11438 Exp. September 16, 2018"
    }
  ]
}