{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222130",
      "product_res_number": "Z-3213-2026",
      "event_date_initiated": "2026-07-06",
      "event_date_posted": "2026-09-17",
      "recall_status": "Open, Classified",
      "res_event_number": "99664",
      "product_code": "SCZ",
      "product_description": "Pi-Cardia Inc.\nShortCut\nREF: Z-A-20.003-US",
      "code_info": "UDI-DI - (01)7290020101242\nAll serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.",
      "firm_fei_number": "3030471525",
      "recalling_firm": "PI CARDIA LTD",
      "address_1": "5, David Pikes St 5 David Pikes St",
      "city": "Rehovot",
      "country": "Israel",
      "additional_info_contact": "Hadas Givon\n972-8-9484800",
      "reason_for_recall": "Transfemoral catheter, positing arm may detached due to weld issue.",
      "root_cause_description": "Process control",
      "action": "On September 3, 2026 Pi-Cardia issued a Urgent Medical Device Recall Update notification to affected consignees via email. This update provided additional information on the risk to health as well as consignee instructions. Original notification was issued  July 9, 2026, Pi Cardia Ltd. informed consignees the following:\n\n\n1. A member of the Pi-Cardia team will contact you promptly with instructions regarding identification and return of any affected inventory. \n\n2. If you have questions in the meantime, please contact your Pi-Cardia representative.\n\n3. Pi-Cardia will provide additional updates as appropriate.",
      "product_quantity": "46 units",
      "distribution_pattern": "US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.",
      "openfda": {
        "k_number": [
          "DEN240017"
        ],
        "registration_number": [
          "3008729892",
          "3030471525",
          "3033307537"
        ],
        "fei_number": [
          "3030471525",
          "3033307537",
          "3002807555"
        ],
        "device_name": "Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1254",
        "device_class": "2"
      }
    }
  ]
}