{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216620",
      "product_res_number": "Z-0509-2026",
      "event_date_initiated": "2025-10-03",
      "event_date_posted": "2025-11-14",
      "recall_status": "Open, Classified",
      "res_event_number": "97806",
      "product_code": "QNR",
      "k_numbers": [
        "K230364",
        "K250199"
      ],
      "product_description": "MC3 VitalFlow Console, REF 58100; Blood pump of ecmo",
      "code_info": "UDI/DI 10850007732247, Serial Numbers:  000023, 000047, 000073, 000100, 000126, 000150, 000173, 000197, 000223,  000024, 000048, 000075, 000101, 000127, 000151, 000174, 000202, 000224,  000025, 000051, 000076, 000102, 000128, 000152, 000177, 000203, 000225,  000027, 000052, 000078, 000103, 000129, 000153, 000179, 000204, 000228,  000028, 000054, 000079, 000104, 000130, 000154, 000180, 000205, 000229,  000029, 000055, 000080, 000106, 000131, 000155, 000181, 000206, 000277,  000030, 000056, 000081, 000108, 000132, 000156, 000182, 000207, 000284,  000031, 000058, 000082, 000109, 000133, 000157, 000183, 000208,  000032, 000059, 000083, 000110, 000134, 000159, 000184, 000209,  000033, 000060, 000084, 000112, 000135, 000161, 000185, 000210,  000034, 000061, 000085, 000115, 000136, 000162, 000186, 000211,  000035, 000063, 000087, 000116, 000140, 000163, 000187, 000212,  000037, 000065, 000088, 000117, 000141, 000165, 000188, 000213,  000038, 000066, 000089, 000118, 000142, 000166, 000189, 000214,  000039, 000067, 000090, 000119, 000143, 000167, 000190, 000215,  000040, 000068, 000092, 000120, 000145, 000168, 000191, 000216,  000043, 000069, 000095, 000121, 000146, 000169, 000192, 000217,  000044, 000070, 000096, 000122, 000147, 000170, 000193, 000218,  000045, 000071, 000097, 000124, 000148, 000171, 000194, 000219,  000046, 000072, 000099, 000125, 000149, 000172, 000195, 000221.",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "reason_for_recall": "As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.",
      "root_cause_description": "Software in the Use Environment",
      "action": "Medtronic Cardiac Surgery issued an Urgent:  Medical Device Correction notice to its consignees on 10/03/2025.  The notice explained the issue, potential harms, and requested the consignee contact Medtronic Sales Representative to schedule the service event to their affected VitalFlow\" Console. Please reference Technical Service Update (TSU) \"MOD0209\"  when scheduling.  The notice also indicated that the consignees use unaffected VitalFlow Console devices, if available, until the correction has been completed.  \nFor questions regarding the communication, please contact your Medtronic Sales Representative.",
      "product_quantity": "167 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K211830",
          "K234118",
          "K223898",
          "K202751",
          "K233736",
          "K222038",
          "K230364",
          "K250199"
        ],
        "registration_number": [
          "3003306248",
          "9617601",
          "2133810",
          "3004593495",
          "1218444",
          "3011468686",
          "9611665",
          "2916596",
          "3010163695"
        ],
        "fei_number": [
          "3003306248",
          "3002807095",
          "3002534070",
          "3000203066",
          "3004593495",
          "1218444",
          "3011468686",
          "2916596",
          "3010163695"
        ],
        "device_name": "Blood Pump For Ecmo, Long-Term (> 6 Hours) Use",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4100",
        "device_class": "2"
      }
    }
  ]
}