{
  "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": [
    {
      "country": "United States",
      "city": "Saint Paul",
      "address_1": "8200 Coral Sea St NE",
      "reason_for_recall": "Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.",
      "address_2": "",
      "product_quantity": "151 (4 US, 147 OUS)",
      "code_info": "Lot Number:  54790, 54860, 54876, 54877, 54878 ,72417, 72419.",
      "center_classification_date": "20150317",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) in states of: NC and  IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.",
      "state": "MN",
      "product_description": "Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065.        The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.",
      "report_date": "20150325",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management",
      "recall_number": "Z-1276-2015",
      "initial_firm_notification": "Visit",
      "product_type": "Devices",
      "event_id": "70644",
      "termination_date": "20151007",
      "more_code_info": "",
      "recall_initiation_date": "20150223",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}