{
  "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": "215977",
      "product_res_number": "Z-0108-2026",
      "event_date_initiated": "2025-09-05",
      "event_date_posted": "2025-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97580",
      "product_code": "OUT",
      "pma_numbers": [
        "P180027",
        "P180027S002"
      ],
      "product_description": "Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827;\n\nFRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X",
      "code_info": "REF/UDI-DI(Lot):\nFRED5019/00811425020388(0000235839), 00842429117163(0000544498);\nFRED5029/00811425020395(0000256343), 00842429117170(0000507209);\nFRED4528/00811425020425(0000265666);\nFRED4026/00811425021033(0000333125, 0000576973);\nFRED5526/00842429117194(0000361117);\nFRED4508/00842429117095(0000372088);\nFRED5514/00842429117187(0000429786, 0000478385);\nFRED3536/00842429117033(0000460268, 0000445555);  \nFRED3511/00842429117002(0000452923);\nFRED5014/00842429117156(0000563591, 0000464401);\nFRED3516/00842429117019(0000513146, 0000531733, 0000536217); \nMV-F451827/04987892121906(0000565094);\n\nXFRED4017-MVE/00842429107508(0000478838);\nXFRED4528-MVE/00842429107560(0000518323, 0000663751);\nMV-F501427X/04987892151231(0000579031);\nXFRED4518-MVE/00842429107553(0000663074, 0000663750);\nXFRED5526-MVE/00842429107638(0000704203);\nXFRED4539-MVE/00842429107577(00007311620);\nFREDX5522-PMA/00842429114483(0000265641, 0000469609, 0000731155);\nFREDX3522-PMA/00842429114315(0000469598);\nFREDX4525-PMA/00842429114414(0000469603);\nFREDX5015-PMA/00842429114445(0000469606);\nFREDX5532-PMA/00842429114490(0000469610);\nFREDX4013-PMA/00842429114346(0000469613, 0000663758, 0000668189);\nFREDX3513-PMA/00842429114292(0000478834);\nFREDX4515-PMA/00842429114391(0000478840);\nFREDX3517-PMA/00842429114308(0000731304);\nMV-F352427X/04987892151101(0000760963)",
      "firm_fei_number": "3013556777",
      "recalling_firm": "MICROVENTION INC.",
      "address_1": "35 Enterprise",
      "city": "Aliso Viejo",
      "state": "CA",
      "postal_code": "92656",
      "additional_info_contact": "Terrence Callahan\n949-899-7194",
      "reason_for_recall": "Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.",
      "root_cause_description": "Device Design",
      "action": "On 9/5/2025, recall notices were mailed to customers who were asked to do the following: \n1) Stop using and quarantine affected devices.\n2) Provide the notice to medical facilities or users to whom you have distributed recalled devices.\n3) Return effected devices.\n4) Complete and return the customer acknowledgement form via email to Terumo8943@sedgwick.com\n\nDirect questions to the firm at terrence.callahan@microvention.com\n\nOn 10/29/2025, additional recall notices were distributed identifying additional distributed devices.",
      "product_quantity": "467",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, KR, SK, MX, DK, IR, SA, BY, PA, VN, ZA, BR, TW, CN, BE, FR, VE, MY.",
      "openfda": {
        "device_name": "Intracranial Aneurysm Flow Diverter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P170024",
          "P180027",
          "P100018"
        ],
        "registration_number": [
          "3015550451",
          "3013556777",
          "2011171",
          "1226348",
          "3010079067",
          "3009380063",
          "3007628272",
          "3019807891",
          "3008853977",
          "3008881809",
          "2029214",
          "3008307705",
          "3008837339",
          "3022418643"
        ],
        "fei_number": [
          "3002947440",
          "3015550451",
          "1000220862",
          "3013556777",
          "2011171",
          "3010079067",
          "3009380063",
          "3007628272",
          "3019807891",
          "3008853977",
          "3008881809",
          "3008307705",
          "3008837339",
          "3022418643"
        ]
      }
    }
  ]
}