{
  "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": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96006",
      "recalling_firm": "ev3 Inc",
      "address_1": "4600 Nathan Ln N",
      "address_2": "",
      "postal_code": "55442-2890",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.",
      "recall_number": "Z-0904-2025",
      "product_description": "Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter",
      "product_quantity": "5189 units",
      "reason_for_recall": "There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.",
      "recall_initiation_date": "20241210",
      "center_classification_date": "20250114",
      "report_date": "20250122",
      "code_info": "1) AB14W050020090, UDI/DI 00763000758035, Serial Numbers:  B738596, B749440, B764968;   2) AB14W050020150, UDI/DI 00763000758042, Serial Numbers:  B761521, B781264, B794814;   3) AB14W050040090, UDI/DI 00763000758059, Serial Numbers:  B740725, B748628;   3) AB14W050040090, UDI/DI 04987742337891, Serial Numbers:  B740725;   4) AB14W050040150, UDI/DI 00763000758066, Serial Numbers:  B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995;   4) AB14W050040150, UDI/DI 04987742337907, Serial Numbers:  B755679;   5) AB14W050060150, UDI/DI 00763000758080, Serial Numbers:  B755683, B761779, B762646, B792990;   6) AB14W050080090, UDI/DI 00763000758097, Serial Numbers:  B797860;   7) AB14W050080150, UDI/DI 00763000758103, Serial Numbers:  B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874;   8) AB14W050100150, UDI/DI none, Serial Numbers:  B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118;   9) AB14W050120150, UDI/DI 00763000758141, Serial Numbers:  B731160, B761782, B762036, B768737, B793229;   10) AB14W050150150, UDI/DI 00763000758165, Serial Numbers:  B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222;   11) AB14W050200090, UDI/DI 00763000758172, Serial Numbers:  B760301, B789934;   11) AB14W050200090, UDI/DI 04987742337815, Serial Numbers:  B760301;   12) AB14W050200150, UDI/DI 00763000758189, Serial Numbers:  B734116, B740732, B749498, B749509, B754865, B754876, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527;    13) AB14W060040090, UDI/DI 00763000758219, Serial Numbers:  B730934, B795892;   14) AB14W060040150, UDI/DI 00763000758226, Serial Numbers:  B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013;   15) AB14W060060150, UDI/DI 00763000758240, Serial Numbers:  B762430, B762853, B791832;   16) AB14W060080150, UDI/DI 00763000758264, Serial Numbers:  B755686, B761181, B762366, B762433, B762921, B793869;   17) AB14W060100150, UDI/DI 00763000758288, Serial Numbers:  B748690, B759617, B762803, B769628, B781383, B792612;   18) AB14W060120150, UDI/DI 00763000758301, Serial Numbers:  B762187, B766265, B789926;   19) AB14W060150150, UDI/DI 00763000758325, Serial Numbers:  B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875;   20) AB14W060200150, UDI/DI 00763000758349, Serial Numbers:  B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379.",
      "more_code_info": ""
    }
  ]
}