{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190351",
      "product_res_number": "Z-0381-2022",
      "event_date_initiated": "2021-11-08",
      "event_date_created": "2021-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-05-02",
      "res_event_number": "89034",
      "product_code": "MCX",
      "product_description": "Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).",
      "code_info": "US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; \n\nEU Serial number RP005010, GTIN 08714729975151.",
      "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": "Ms. Rebecca KinKead Rubio\n763-494-1133",
      "reason_for_recall": "Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.",
      "root_cause_description": "Employee error",
      "action": "The recalling firm issued letters dated 11/8/2021 on the same date and flagged \"Urgent Medical Device Removal - Immediate Action Required.\"  It explains the reason for recall, the risk to health, and provides removal instructions.  The instructions say to immediately discontinue use of and segregate the affected product.  A Reply Verification Tracking Form is enclosed for immediate completion and return.  The customer will be contacted by BSC and provided a Returned Goods Authorization  for return of the device.",
      "product_quantity": "7 devices",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.",
      "openfda": {
        "pma_number": [
          "P890043",
          "P910019",
          "P980037",
          "P900056",
          "P130005"
        ],
        "registration_number": [
          "2134265",
          "3002807314",
          "1225687",
          "2126666",
          "3003708554",
          "1000121056",
          "3010273872",
          "2124215",
          "3004091615",
          "9616684",
          "1643817",
          "9681260",
          "3002631703",
          "3010220595",
          "3014479313",
          "3004742232",
          "2183744",
          "3008814558",
          "3021632375",
          "3007695959",
          "3000279201",
          "2648729",
          "2133810",
          "3011120183"
        ],
        "fei_number": [
          "3002913962",
          "3002807314",
          "2126666",
          "3002095335",
          "3000203066",
          "3003708554",
          "1000121056",
          "3010273872",
          "2124215",
          "3004091615",
          "1643817",
          "3002631703",
          "3010220595",
          "3014479313",
          "3004742232",
          "2183744",
          "3008814558",
          "3021632375",
          "3007695959",
          "3002806565",
          "3000279201",
          "2648729",
          "3011120183",
          "3001451463"
        ],
        "device_name": "Catheter, Coronary, Atherectomy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}