{
  "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": "Elkton",
      "state": "MD",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82705",
      "recalling_firm": "Terumo Medical Corporation",
      "address_1": "950 Elkton Blvd",
      "address_2": "N/A",
      "postal_code": "21921-5322",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The products were distributed US nationwide.    The products were distributed to the following foreign countries:  Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.",
      "recall_number": "Z-1374-2019",
      "product_description": "SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425,   STFI-1435,   STFI-1625,   STFI-1635,   STFI-1825,   STFI-1835,   STFI-1925,   STFI-1935,   STFI-2125,   STFI-2135    Product Usage:  The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.",
      "product_quantity": "2228",
      "reason_for_recall": "There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.",
      "recall_initiation_date": "20190426",
      "center_classification_date": "20190528",
      "termination_date": "20200922",
      "report_date": "20190605",
      "code_info": "Lot Codes: UG22  UG28A  UK02  VA20  VN17  UG22  UK26  VA25  VC15  VG22  VN30  UH29  VA05  VG07  VG26  UH29  VH21  VK29  UH29  UK30  UP20  VF31  WG13  WK30  UH28  UK26  UL28  VD09  VH31  VM19  WP12  UG22  UG22A  UH27  UH27A  UL14  VA19  VG22  VM24  VP13  WG13  WL28  UG22  UH29  UL14  UL28  UN16  UP20  VA13  VC15  VD09  VH28  VK21  VL06  VL28  VM24  VN21  WG13  XA30  UG22  UL14  UN28  VH27  WM31  UN28  VG02  VP07  WN07"
    }
  ]
}