{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193386",
      "product_res_number": "Z-1131-2022",
      "event_date_initiated": "2022-04-20",
      "event_date_created": "2022-05-25",
      "recall_status": "Open, Classified",
      "res_event_number": "90089",
      "product_code": "OCL",
      "k_numbers": [
        "K121767",
        "K200514"
      ],
      "product_description": "Cardioblate\" Gemini\"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.",
      "code_info": "ABLATION DEVICE 49260 PROCEDURE KIT Model 49260; GTIN: 00613994268051, Lot Numbers: 215G, 256E, 388C, 466C, 584D, 611A, 745F, 840C, 850C, 967C; GTIN: 00613994755643, Lot Numbers: 469C, 612A, 972C, 973C, GTIN: 00643169983120, Lot Numbers: 125E, 238D, 257E, 258E, 259E, 335D, 373B, 410E, 428D, 454F, 467C, 585D, 632E, 635F, 700D, 721C, 722C, 732E, 735E, 738E, 841C, 876E, 923D, 968C, 972E, 980E, 995D.\n\nCLAMP 49351 CARDIOBLATE GEMINI-S FT Model: 49351; GTIN: 00643169998117, Lot Numbers: 495F, 734E, 846D.",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "additional_info_contact": "Medtronic Customer Service\n1800-854-3570",
      "reason_for_recall": "Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.",
      "root_cause_description": "Labeling design",
      "action": "A recall notification was sent to consignees on 04/20/2022 via the United Parcel Service. The letter instructs the consignees to review the updated guidance on device usage contained in the letter, share the notice to those that need to be aware, and complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com.",
      "product_quantity": "1236 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerland.",
      "openfda": {
        "k_number": [
          "K190587",
          "K063012",
          "K142084",
          "K223508",
          "K022008",
          "K121767",
          "K970496",
          "K090202",
          "K974320",
          "K050459",
          "K121451",
          "K121878",
          "K021010",
          "K073605",
          "K053436",
          "K011988",
          "K122611",
          "K211311",
          "K041890",
          "K071819",
          "K062140",
          "K110913",
          "K082279",
          "K100501",
          "K120857",
          "K090721",
          "K234151",
          "K130521",
          "K080509",
          "K191526",
          "K193162",
          "K163408",
          "K190623",
          "K182610",
          "K110117",
          "K190151",
          "K252056",
          "K101174",
          "K061593",
          "K082203",
          "K060715",
          "K113475",
          "K221358",
          "K070288",
          "K011040",
          "K040690",
          "K080292",
          "K210477",
          "K013392",
          "K192125",
          "K183065",
          "K200514",
          "K043579",
          "K123733"
        ],
        "registration_number": [
          "1721676",
          "3008262715",
          "3009882464",
          "1047843",
          "3005012805",
          "3003955307",
          "2087259",
          "3018094310",
          "1721983",
          "2954783",
          "2028523",
          "3008592544",
          "3035387162",
          "1717344",
          "2184009",
          "3008729892",
          "9616793",
          "2134265",
          "3011706110",
          "1036836",
          "2124215",
          "3026612481",
          "9611854",
          "9616065",
          "2528981",
          "2182291",
          "2133810",
          "1423662",
          "1928237"
        ],
        "fei_number": [
          "1721676",
          "3008262715",
          "3009882464",
          "1047843",
          "3005012805",
          "3002807555",
          "3003955307",
          "3018094310",
          "3000203066",
          "3002095335",
          "3008592544",
          "3035387162",
          "1717344",
          "3002807258",
          "1000064530",
          "1000116158",
          "3011706110",
          "1036836",
          "2124215",
          "3026612481",
          "1000125147",
          "3002843919",
          "2528981",
          "1000531402",
          "3003186357",
          "3003381355",
          "2182291",
          "3000215273",
          "1928237"
        ],
        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}