{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192430",
      "product_res_number": "Z-0927-2022",
      "event_date_initiated": "2022-03-02",
      "event_date_posted": "2022-04-18",
      "recall_status": "Open, Classified",
      "res_event_number": "89754",
      "product_code": "NPV",
      "pma_numbers": [
        "P200046"
      ],
      "product_description": "Harmony Delivery Catheter System.  Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.",
      "code_info": "HARMONY-DCS (GTIN: 00763000341367); \nLot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593",
      "firm_fei_number": "3001504994",
      "recalling_firm": "Medtronic Inc",
      "address_1": "710 Medtronic Pkwy Mailstop Ls245",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-5603",
      "additional_info_contact": "Medtronic Customer Service\n800-854-3570",
      "reason_for_recall": "There is potential for the capsule bond to break during the procedure.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beginning 02-MAR-2022 Medtronic initiated communications of an Urgent Medical Device Notice letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records.\nConsignees are asked to review the Medtronic Urgent Medical Device Notice notification and follow the Recommended Actions. \nImplanting physicians associated with related valves to the Harmony DCS were included in notifications, though these valve products are not subject to the recall issue.\nAdditional verbal communication was initiated for a full product recall on March 24. Written communications were mailed on April 5, 2022 stating that Medtronic is recommending an immediate suspension of the Harmony DCS product use and is undertaking a voluntarily recall of the Harmony DCS.",
      "product_quantity": "1483 devices",
      "distribution_pattern": "US Nationwide and the countries of Canada.",
      "openfda": {
        "pma_number": [
          "P200015",
          "P200046",
          "P140017"
        ],
        "registration_number": [
          "3007063218",
          "3002807314",
          "2015691",
          "1721676",
          "2528981",
          "2024024",
          "3008500478",
          "1318694",
          "3017298588",
          "2011171",
          "3044156918",
          "9612164",
          "2025587",
          "9617601"
        ],
        "fei_number": [
          "3007063218",
          "1713910",
          "3002807314",
          "2015691",
          "1721676",
          "2528981",
          "3002806434",
          "2024024",
          "3017298588",
          "1318694",
          "2011171",
          "3044156918",
          "3002534070",
          "2025587"
        ],
        "device_name": "Pulmonary Valve Prosthesis Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f"
      }
    }
  ]
}