{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "214302",
      "product_res_number": "Z-2103-2025",
      "event_date_initiated": "2025-06-10",
      "event_date_posted": "2025-07-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97036",
      "product_code": "DXF",
      "k_numbers": [
        "K150709",
        "K183655"
      ],
      "product_description": "VersaCross Access Solution (VXSK),\nProduct Description and ID:\n\nVXSK (180J RF WIRE 63CM/45DEG/D0)\nVXSK0101\nVXSK (180J RF WIRE 63CM/45DEG/D1)\nVXSK0102\nVXSK (180J RF WIRE 63CM/55DEG/D0)\nVXSK0103\nVXSK (180P RF WIRE 63CM/45DEG/D0)\nVXSK0121\nVXSK (180P RF WIRE 63CM/45DEG/D1)\nVXSK0122\nVXSK (180P RF WIRE 63CM/55DEG/D0)\nVXSK0123\nVXSK (180P RF WIRE 63CM/55DEG/D1)\nVXSK0124\nVXSK (180P RF WIRE 63CM/90DEG/D0)\nVXSK0125\nVXSK (230J RF WIRE 63CM/45DEG/D0)\nVXSK0111\nVXSK (230J RF WIRE 63CM/45DEG/D1)\nVXSK0112\nVXSK (230P RF WIRE 63CM/45DEG/D0)\nVXSK0131\nVXSK (230P RF WIRE 63CM/45DEG/D1)\nVXSK0132\nVXSK (230P RF WIRE 63CM/55DEG/D0)\nVXSK0133\nVXSK (230P RF WIRE 63CM/55DEG/D1)\nVXSK0134\nVXSK (230P RF WIRE 81CM/45DEG/D0)\nVXSK0137\nVXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH\nVXSK0021\nVXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH\nVXSK0022\nVXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH\nVXSK0024\nVXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH\nVXSK0025\nVXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH\nVXSK0031\nVXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH\nVXSK0032\nVXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH\nVXSK0034",
      "code_info": "Product ID/UDI-DI/Batch Numbers:\n\nVXSK0021\nUDI-DI 00685447011729\nLots 35590858\n35607785\n35627540;\n\nVXSK0022\nUDI-DI 00685447011736\nLots 35487923\n35544014\n35552652\n35566071\n35595443\n35604160\n35616857\n\nVXSK0024\nUDI-DI 00685447011750\nLot 35576278;\n\nVXSK0025\nUDI-DI 00685447011767\nLot 35582041;\nVXSK0031\nUDI-DI 00685447011828\nLots 35499536\n35627156;\n\nVXSK0032\nUDI-DI 00685447011835\nLots 35508294\n35518904\n35563958\n35582043\n35635451;\n\nVXSK0034\nUDI-DI 00685447011859\nLots 35573519\n35593310;\n\nVXSK0101\nUDI-DI 00685447019749\nLot 35893570;\n\nVXSK0102\nUDI-DI 00685447019756\nLot 35720571;\n\nVXSK0103\nUDI-DI 00685447019763\nLot 36042383;\n\nVXSK0111\nUDI-DI 00685447019794\nLot 35944186;\n\nVXSK0112\nUDI-DI 00685447019800\nLot 36061050;\n\nVXSK0121\nUDI-DI 00685447019817\nLots 35745702\n35787463;\n\nVXSK0122\nUDI-DI 00685447019824\nLots 35699501\n35720572\n35768613\n35780309\n35790937\n35830237\n35833400;\n\nVXSK0123\nUDI-DI 00685447019831\nLot 35843757;\n\nVXSK0124\nUDI-DI 00685447019848\nLots 35697863\n35883199;\n\nVXSK0125\nUDI-DI 00685447019855\nLot 35859706;\n\nVXSK0131\nUDI-DI 00685447019862\nLots 35729751\n35807530\n35900608;\n\nVXSK0132\nUDI-DI 00685447019879\nLots 35695371\n35729750\n35807531\n35910367\n35955008;\n\nVXSK0133\nUDI-DI 00685447019886\nLot 35839894;\n\nVXSK0134\nUDI-DI 00685447019893\nLot 35666909;\n\nVXSK0137\nUDI-DI 00685447019909\nLot 35985522",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "Clara Johnson\n651-582-4000",
      "reason_for_recall": "Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.",
      "root_cause_description": "Packaging change control",
      "action": "On June 10, 2025, the firm began notifying consignees of the field action via Urgent Medical Device Removal letters. Customers are instructed to not use affected product. They should remove affected units from their inventory and segregate the units in a secure place until they can be returned to Boston Scientific.",
      "product_quantity": "14,724",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.",
      "openfda": {
        "k_number": [
          "K261745",
          "K241414",
          "K221528",
          "K240900",
          "K211910",
          "K860806",
          "K011557",
          "K260292",
          "K232852",
          "K242076",
          "K150709",
          "K252419",
          "K001804",
          "K182399",
          "K253799",
          "K031949",
          "K243193",
          "K251007",
          "K801031",
          "K990284",
          "K073326"
        ],
        "registration_number": [
          "2126666",
          "3020968442",
          "3012833053",
          "1225687",
          "3040993693",
          "3010273872",
          "2183744",
          "2246552",
          "1319639",
          "3029895042",
          "1318694",
          "1820334",
          "1424263",
          "9618000",
          "1424785",
          "2015691",
          "2030624",
          "3013986346",
          "3019751610",
          "3013666336",
          "1000121056",
          "3009437315",
          "1047843",
          "2528981",
          "2124215",
          "3039000024",
          "3025341484",
          "3009420598"
        ],
        "fei_number": [
          "2126666",
          "3020968442",
          "3012833053",
          "3003245778",
          "3040993693",
          "3010273872",
          "2183744",
          "2246552",
          "3029895042",
          "1318694",
          "1820334",
          "1000138054",
          "2015691",
          "3003473212",
          "3013986346",
          "3019751610",
          "3013666336",
          "1000121056",
          "3000206435",
          "3009437315",
          "3003015552",
          "3001451463",
          "1047843",
          "2528981",
          "2124215",
          "3039000024",
          "3025341484",
          "3009420598"
        ],
        "device_name": "Catheter, Septostomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5175",
        "device_class": "2"
      }
    }
  ]
}