{
  "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": "195423",
      "product_res_number": "Z-1571-2022",
      "event_date_initiated": "2022-07-26",
      "event_date_created": "2022-08-24",
      "recall_status": "Open, Classified",
      "res_event_number": "90686",
      "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 for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On about 07/26/2022, Medtronic notified consignees via mail courier service with a letter titled \"URGENT: MEDICAL DEVICE CORRECTION.\"  The letter instructed consignees to perform an initial interrogation of the Vanta INS and tap  start usage,  tap  implant\ndevice  workflow, click  start,  and on the next screen exit the session, and to initiate a second interrogation and if there is no \"Unexpected Device Error Code 1502\" code the INS maybe used.  If the INS cannot be interrogated, contact Medtronic Technical Services at 1-800-707-0933.  Additionally, consignees were instructed to complete and return the customer confirmation form provided.",
      "product_quantity": "2,920 downloaded software applications",
      "distribution_pattern": "Worldwide distribution - US Nationwide 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, 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",
          "2135338",
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          "1627487",
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          "2133772",
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        "fei_number": [
          "3002806500",
          "3008988055",
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          "3010052483",
          "3015200795",
          "2182207",
          "3009380063",
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          "3005700659",
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          "3002618605",
          "3000206435",
          "3019807891",
          "3015924373",
          "3013023969",
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          "3010972758",
          "2183744",
          "1035166",
          "3000203466",
          "1928237",
          "3008514029",
          "3014507028",
          "3003120897",
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          "3003477135",
          "3000209794",
          "3006630150",
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          "3005210579",
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          "3005160949",
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          "3003574398",
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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"
      }
    }
  ]
}