{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "192363",
      "product_res_number": "Z-0915-2022",
      "event_date_initiated": "2022-03-08",
      "event_date_created": "2022-04-12",
      "recall_status": "Open, Classified",
      "res_event_number": "89753",
      "product_code": "MCX",
      "pma_numbers": [
        "P900056"
      ],
      "product_description": "ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy",
      "code_info": "ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 \nIndividual units within 5-pack are labeled as Single, UPN: H74939462001\n\nBatch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019\n27756205, 27756933, and 27756935\n\nGTIN: 08714729996255",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "Rebecca Kinkead Rubio\n763-494-1133",
      "reason_for_recall": "Pouch seals may be open, compromising sterility.",
      "root_cause_description": "Process control",
      "action": "US consignees were mailed an overnight delivery of the customer letter.  OUS consignees will be contacted by letter delivery or email.\nAccounts are asked to return any unused affected devices to the recalling firm.  The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions.",
      "product_quantity": "433 5-packs",
      "distribution_pattern": "Distribution in the US and territories, Japan, and Canada",
      "openfda": {
        "device_name": "Catheter, Coronary, Atherectomy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P980037",
          "P130005",
          "P890043",
          "P910019",
          "P900056"
        ],
        "registration_number": [
          "1643817",
          "2648729",
          "3004091615",
          "3002631703",
          "3004742232",
          "2183744",
          "3008814558",
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          "3003708554",
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        ],
        "fei_number": [
          "1643817",
          "2648729",
          "3004091615",
          "3001451463",
          "3002631703",
          "3004742232",
          "2183744",
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      }
    }
  ]
}