{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
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      "cfres_id": "188265",
      "product_res_number": "Z-2159-2021",
      "event_date_initiated": "2021-07-09",
      "event_date_created": "2021-07-28",
      "recall_status": "Open, Classified",
      "res_event_number": "88272",
      "product_code": "LGW",
      "pma_numbers": [
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      "product_description": "Medtronic Vectris SureScan MRI, Catalog Numbers:\na) 977A260\nb) 977A275\nc) 977A290",
      "code_info": "a) 977A260, PIN 977A20024V, UDI 00763000324353\nb) 977A275, PIN 977A20025V, UDI 00763000324360\nc) 977A290, PIN 977A20028V, UDI 00763000324377",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "reason_for_recall": "Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.",
      "root_cause_description": "Error in labeling",
      "action": "The firm initiated the recall on 07/07/2021 by regionally approve method (e.g.  courier, registered mail, hand delivery).  The firm is requesting the return of the devices.",
      "product_quantity": "1131 units",
      "distribution_pattern": "Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom",
      "openfda": {
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        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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    }
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}