{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195420",
      "product_res_number": "Z-1574-2022",
      "event_date_initiated": "2022-07-26",
      "event_date_posted": "2022-08-25",
      "recall_status": "Open, Classified",
      "res_event_number": "90685",
      "product_code": "LGW",
      "product_description": "Vanta Clinician Programmer Application, Model A71200.  For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.",
      "code_info": "Model A71200; Software Version 2.0.2455",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "additional_info_contact": "Michelle Claypool\n763-526-9452",
      "reason_for_recall": "Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta\nImplantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On about 07/26/2022, Medtronic notified consignees via letter titled \"URGENT: MEDICAL DEVICE CORRECTION\" sent through courier service.  The notification instructed consignees to hold off implanting more than one Vanta INS in a patient until software update is available and while not recommended, if implanting a patient with two (2) Vanta INSs, ensure the INSs are implanted on opposite sides of the body as noted in the Information for Prescribers labeling, and ensure each is configured with the CP App before implanting in a patient.  Consignees were asked to complete and return the customer confirmation form provided an contact Medtronic Technical Services at 1-800-707-0933 if troubleshooting does not resolve any issues encountered.",
      "product_quantity": "4386 downloaded software applications",
      "distribution_pattern": "Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.",
      "openfda": {
        "pma_number": [
          "P030017",
          "P130028",
          "P010032",
          "P130022",
          "P190002",
          "P210037",
          "P800040",
          "P840001"
        ],
        "registration_number": [
          "9681477",
          "3008988055",
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        "fei_number": [
          "3002806500",
          "3008988055",
          "3021836309",
          "3010052483",
          "3015200795",
          "2182207",
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          "3005846326",
          "3005700659",
          "2648729",
          "3002618605",
          "3000206435",
          "3019807891",
          "3015924373",
          "3013023969",
          "2124215",
          "3010966701",
          "3010972758",
          "2183744",
          "1035166",
          "3000203466",
          "1928237",
          "3008514029",
          "3014507028",
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          "3000209794",
          "3006630150",
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          "3005210579",
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          "3002807439",
          "3006705815",
          "3013368220",
          "3012693387",
          "3004369318",
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        ],
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}