{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "25950",
      "product_res_number": "Z-0625-03",
      "event_date_initiated": "2003-01-31",
      "event_date_posted": "2003-03-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-05-01",
      "res_event_number": "25514",
      "product_code": "LOX",
      "k_numbers": [
        "K942269"
      ],
      "product_description": "Medtronic AVE Everest PTCA Inflation Catheter 20 cc\nItem #AC2200",
      "code_info": "Lot Numbers: 122851, 12852, 122853",
      "firm_fei_number": "1220452",
      "recalling_firm": "Medtronic, Inc.",
      "address_1": "35-37A Cherry Hill Drive",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923",
      "additional_info_contact": "Fred L. Boucher\n978-739-3116",
      "reason_for_recall": "PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon",
      "root_cause_description": "Other",
      "action": "Medtronic AVE notified the  two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.",
      "product_quantity": "602 units",
      "distribution_pattern": "Japan",
      "openfda": {
        "k_number": [
          "K896108",
          "K123264",
          "K252116",
          "K110133",
          "K153742",
          "K150292",
          "K212393",
          "K133633",
          "K820410",
          "K251970",
          "K861847",
          "K162209",
          "K123279",
          "K163174",
          "K220634",
          "K180040",
          "K242969",
          "K121196",
          "K180921",
          "K110617",
          "K261428",
          "K103095",
          "K153682",
          "K163114",
          "K141236",
          "K261759",
          "K121222",
          "K203390",
          "K121667",
          "K152485",
          "K220629",
          "K122178",
          "K211807",
          "K211393",
          "K141025",
          "K230374",
          "K141090",
          "K160823",
          "K160961",
          "K143480",
          "K141933",
          "K143160",
          "K130391",
          "K131450",
          "K113775",
          "K182699",
          "K233729",
          "K162625",
          "K181023",
          "K223189",
          "K160985",
          "K211349",
          "K134031",
          "K210012",
          "K111544",
          "K131169",
          "K223022",
          "K173581",
          "K843944",
          "K163200",
          "K103808",
          "K103153",
          "K112735",
          "K103110",
          "K163372",
          "K172264",
          "K133852",
          "K111284",
          "K202619",
          "K163660",
          "K123473",
          "K200269",
          "K170941",
          "K254022",
          "K162434",
          "K222538",
          "K192344",
          "K113464",
          "K230705",
          "K233499",
          "K121681",
          "K173680",
          "K233505",
          "K113220",
          "K202578",
          "K252295",
          "K103657",
          "K110134"
        ],
        "pma_number": [
          "P990008",
          "P860019",
          "P880003",
          "P930012",
          "P870021",
          "P970052",
          "P790017",
          "P880027",
          "P950020",
          "P850021",
          "P890048",
          "P960014",
          "P910031",
          "P890032",
          "P940009",
          "P840040",
          "P880065",
          "P870036",
          "P810046",
          "P020037",
          "P880055",
          "P890001"
        ],
        "registration_number": [
          "",
          "3010432890",
          "3011564431",
          "3015453963",
          "3009018440",
          "3002807315",
          "3004824117",
          "2124215",
          "3013152301",
          "3009965866",
          "8010026",
          "3006946276",
          "3014222368",
          "3016678045",
          "3006550224",
          "3008700817",
          "3013341368",
          "3002807314",
          "8043892",
          "3018805824",
          "2011171",
          "2134812",
          "1000121056",
          "1225687",
          "1721686",
          "3013546453",
          "3008824097",
          "3007156625",
          "3003898360",
          "3012693555",
          "3014461810",
          "3004091615",
          "3012050423",
          "3015002281",
          "3030421123",
          "3031550970",
          "2134265",
          "3004415014",
          "3003775186",
          "3008573567",
          "3030236028",
          "3013634084",
          "3014656749",
          "3008002401",
          "3017961114",
          "1313046",
          "1422634",
          "9617601",
          "3007836437",
          "2024168",
          "3010131137",
          "9681834",
          "3009205152",
          "3012167431",
          "9612164",
          "3044156918",
          "3024893679",
          "9614654",
          "3014390222",
          "3019807891",
          "3003084171",
          "3009564766",
          "3015910259",
          "3010220595",
          "3043534762",
          "2183744",
          "1319639",
          "1028232",
          "2939561",
          "3010273872",
          "9681260",
          "3006513822",
          "3013944123",
          "3011137372",
          "3009613036",
          "3017262662",
          "3035111606",
          "3010391265",
          "9710284",
          "3034695832"
        ],
        "fei_number": [
          "",
          "3010432890",
          "3011564431",
          "3015453963",
          "1000138054",
          "3005747797",
          "3009018440",
          "3002807315",
          "3004824117",
          "3002808050",
          "3001451463",
          "2124215",
          "3013152301",
          "2828",
          "3009965866",
          "3002827704",
          "1000514656",
          "3006946276",
          "3002808904",
          "3002808327",
          "3014222368",
          "3002806434",
          "3016678045",
          "3006550224",
          "3008700817",
          "3013341368",
          "3002807314",
          "3018805824",
          "2011171",
          "1000121056",
          "1721686",
          "3013546453",
          "3008824097",
          "3003898360",
          "3012693555",
          "3002806565",
          "3014461810",
          "3004091615",
          "3012050423",
          "3015002281",
          "3030421123",
          "3031550970",
          "3004635528",
          "3004415014",
          "3003775186",
          "3008573567",
          "3008133910",
          "3030236028",
          "3013634084",
          "3014656749",
          "3008002401",
          "3017961114",
          "1313046",
          "3002095335",
          "3002534070",
          "3007836437",
          "2024168",
          "3010131137",
          "3009205152",
          "3012167431",
          "3044156918",
          "3024893679",
          "3014390222",
          "3019807891",
          "3003084171",
          "3009564766",
          "3003182398",
          "3015910259",
          "3010220595",
          "3043534762",
          "2183744",
          "1028232",
          "3010273872",
          "3006513822",
          "3013944123",
          "3009613036",
          "3017262662",
          "3035111606",
          "3010391265",
          "3034695832"
        ],
        "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5100",
        "device_class": "2"
      }
    }
  ]
}