{
  "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": "184812",
      "product_res_number": "Z-0775-2021",
      "event_date_initiated": "2020-12-01",
      "event_date_created": "2021-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-07-14",
      "res_event_number": "86909",
      "product_code": "PCU",
      "k_numbers": [
        "K181905"
      ],
      "product_description": "AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.",
      "code_info": "Lot Number: 26167271, 26152176,26167274 Exp. Date Range: 10/8/2021   10/12/2021  GTIN: 08714729951179",
      "firm_fei_number": "3005099803",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-1291",
      "additional_info_contact": "Nicole Pshon\n763-494-1556",
      "reason_for_recall": "The rotating luer fitting at the distal end of the\ndelivery system handle may become detached from the nose of the delivery  during device preparation, stent delivery or use, resulting in delay or procedure or\nrisk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity",
      "root_cause_description": "Process control",
      "action": "Boston Scientific issued  customer notification letters to consignees  via Federal Express Priority Overnight mail on December 1, 2020. The letter states reason for recall, health risk and action to take:\nCease further distribution or use of any remaining product affected by this\nremoval immediately.\nVerify by product lot/batch number in the product table whether any product\nwithin your inventory is affected. If so, indicate on your Reply Verification\nTracking Form the quantity of units from each lot/batch that you will be returning.\nIf you identify any product from the affected lots/batches within your inventory,\nplease segregate the product immediately and return it to BSC in accordance\nwith the enclosed instructions. If you are a distributor, please note that the\ndepth of this removal is to the end user level and this notification should be\nforwarded to your customers. If you are a facility that has sent products to\nanother hospital or facility within your network, please ensure that this\nnotification is forwarded to them.\n\nYour local Sales Representative can answer any questions that you\nmay have regarding this notification.",
      "product_quantity": "38 units",
      "distribution_pattern": "US Nationwide distribution - Foreign: TBD.",
      "openfda": {
        "k_number": [
          "K152572",
          "DEN130007",
          "K163272",
          "K150692",
          "K203132",
          "K192043",
          "K140561",
          "K181905",
          "K220112",
          "K153088",
          "K252648"
        ],
        "device_name": "Pancreatic Stent, Covered, Metallic, Removable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5015",
        "device_class": "2",
        "registration_number": [
          "3002807314",
          "9681260",
          "2024311",
          "1000121056",
          "3005099803",
          "3003902943",
          "3010273872"
        ],
        "fei_number": [
          "3002807314",
          "3002806565",
          "2024311",
          "1000121056",
          "3005099803",
          "3003902943",
          "3010273872"
        ]
      }
    }
  ]
}