{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Aliso Viejo",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97580",
      "recalling_firm": "MICROVENTION INC.",
      "address_1": "35 Enterprise",
      "address_2": "",
      "postal_code": "92656",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0108-2026",
      "product_description": "Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827;  FRED 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",
      "product_quantity": "467",
      "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.",
      "recall_initiation_date": "20250905",
      "center_classification_date": "20251010",
      "report_date": "20251022",
      "code_info": "REF/UDI-DI(Lot): FRED5019/00811425020388(0000235839), 00842429117163(0000544498); FRED5029/00811425020395(0000256343), 00842429117170(0000507209); FRED4528/00811425020425(0000265666); FRED4026/00811425021033(0000333125, 0000576973); FRED5526/00842429117194(0000361117); FRED4508/00842429117095(0000372088); FRED5514/00842429117187(0000429786, 0000478385); FRED3536/00842429117033(0000460268, 0000445555);   FRED3511/00842429117002(0000452923); FRED5014/00842429117156(0000563591, 0000464401); FRED3516/00842429117019(0000513146, 0000531733, 0000536217);  MV-F451827/04987892121906(0000565094);  XFRED4017-MVE/00842429107508(0000478838); XFRED4528-MVE/00842429107560(0000518323, 0000663751); MV-F501427X/04987892151231(0000579031); XFRED4518-MVE/00842429107553(0000663074, 0000663750); XFRED5526-MVE/00842429107638(0000704203); XFRED4539-MVE/00842429107577(00007311620); FREDX5522-PMA/00842429114483(0000265641, 0000469609, 0000731155); FREDX3522-PMA/00842429114315(0000469598); FREDX4525-PMA/00842429114414(0000469603); FREDX5015-PMA/00842429114445(0000469606); FREDX5532-PMA/00842429114490(0000469610); FREDX4013-PMA/00842429114346(0000469613, 0000663758, 0000668189); FREDX3513-PMA/00842429114292(0000478834); FREDX4515-PMA/00842429114391(0000478840); FREDX3517-PMA/00842429114308(0000731304); MV-F352427X/04987892151101(0000760963)",
      "more_code_info": ""
    }
  ]
}