{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "cfres_id": "182414",
      "product_res_number": "Z-2759-2020",
      "event_date_initiated": "2020-07-06",
      "event_date_created": "2020-08-05",
      "recall_status": "Open, Classified",
      "res_event_number": "86004",
      "product_code": "FDI",
      "k_numbers": [
        "K131700"
      ],
      "product_description": "Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can\nbe extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide\" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.",
      "code_info": "Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23",
      "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\n508-683-4000",
      "reason_for_recall": "BSC has noted a potential inability to cut and\nremove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.",
      "root_cause_description": "Device Design",
      "action": "BSC will sent the customer communication package on July 6, 2020. The communication package includes a Customer Letter and a Reply Verification Tracking Form.",
      "distribution_pattern": "World wide distribution.",
      "openfda": {
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          "K943935",
          "K930022",
          "K221713",
          "K083049",
          "K150316",
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          "K951600",
          "K220846",
          "K893553",
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          "K894869",
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          "K011667",
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          "K022268",
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          "K151197",
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          "K133987",
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          "K955650",
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          "K191048",
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          "K971275",
          "K251692",
          "K992477",
          "K911482",
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          "K122462",
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          "K901428",
          "K050294",
          "K152580",
          "K140726",
          "K902265",
          "K940335",
          "K183289",
          "K901322",
          "K140923",
          "K172734",
          "K220790",
          "K912254",
          "K173673",
          "K923031",
          "K040961"
        ],
        "registration_number": [
          "3011193403",
          "1223925",
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          "3010707607",
          "2020550",
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          "3007738736",
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          "3011146996",
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        ],
        "fei_number": [
          "3011193403",
          "1000122656",
          "3004083736",
          "1222168",
          "3005987240",
          "3002806816",
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          "3009888344",
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          "3006696607",
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          "1000305720",
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          "3004837686",
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          "3010707607",
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          "3002995060",
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          "3008185830",
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          "2528981",
          "3007738736",
          "3002808268",
          "3011050570",
          "3011146996",
          "3001451463"
        ],
        "device_name": "Snare, Flexible",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4300",
        "device_class": "2"
      }
    }
  ]
}