{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "217454",
      "product_res_number": "Z-0996-2026",
      "event_date_initiated": "2025-11-20",
      "event_date_posted": "2025-12-23",
      "recall_status": "Open, Classified",
      "res_event_number": "98028",
      "product_code": "LGW",
      "pma_numbers": [
        "P840001S594"
      ],
      "product_description": "Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:\n\nCT900A PROG CT900A CLINICIAN TABLET US\nCT900B PROG CT900B CLINICIAN TABLET EU -UK\nCT900C PROG CT900C CLINICIAN TABLET UK\nCT900D PROG CT900D CLINICIAN TABLET GLOBAL\nCT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG\nCT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG",
      "code_info": "CP App: UDI-DI 00763000273668\nall software versions prior to v.1.0.4489 are affected\n\nThe implanted devices are not affected.",
      "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": "Naomi Rodiles\n763-514-2000",
      "reason_for_recall": "Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.",
      "root_cause_description": "Software design",
      "action": "On November 20, 2025, the firm notified customers via Urgent Medical Device Safety Notification letters. Medtronic has developed a new version of the A71100 CP App, v1.0.4489 or later, that contains a fix for this issue by ensuring the ability to clear a Device Reset message by pressing  OK  if the message appears.\n\nCustomers should download v1.0.4489 or any later version at your earliest convenience.",
      "product_quantity": "7667 devices",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, \nAustria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, \nColombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, \nEl Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong, \nHungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, \nMalta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, \nPeru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.",
      "openfda": {
        "pma_number": [
          "P030017",
          "P130022",
          "P840001",
          "P010032",
          "P210037",
          "P190002",
          "P130028",
          "P800040"
        ],
        "registration_number": [
          "2133772",
          "3012693387",
          "2648729",
          "3038429246",
          "3006630150",
          "3013368220",
          "2183744",
          "3010966701",
          "3016618265",
          "9681477",
          "2133810",
          "3015173212",
          "3019807891",
          "9610139",
          "1035166",
          "3018094310",
          "3007882731",
          "2133641",
          "1627487",
          "2649622",
          "3009380063",
          "3010052483",
          "3004209178",
          "3020969413",
          "3014507028",
          "1928237",
          "2182207",
          "2135338",
          "3013973539",
          "3010972758",
          "2124215",
          "3013023969",
          "3015924373",
          "2134604",
          "3003120897",
          "2182291",
          "3015200795",
          "9616693",
          "2024311",
          "3003477135",
          "3008988055",
          "3003335547",
          "3005160949",
          "2030624",
          "3008514029",
          "3007616088",
          "3004593495",
          "2032521",
          "3027063190",
          "3021836309",
          "3010326622",
          "3010086866",
          "3010531069",
          "3005210579",
          "3006705815",
          "3004519921"
        ],
        "fei_number": [
          "3012693387",
          "2648729",
          "3038429246",
          "3006630150",
          "3013368220",
          "2183744",
          "3002806500",
          "3005700659",
          "3010966701",
          "3016618265",
          "3000206435",
          "3005846326",
          "3003574398",
          "3000209794",
          "3015173212",
          "3019807891",
          "3002623849",
          "1035166",
          "3018094310",
          "3007882731",
          "1627487",
          "2649622",
          "3009380063",
          "3010052483",
          "3002618605",
          "3020969413",
          "3014507028",
          "1928237",
          "3000203466",
          "3000203066",
          "2182207",
          "3013973539",
          "3010972758",
          "2124215",
          "3013023969",
          "3002807439",
          "3015924373",
          "3003120897",
          "2182291",
          "3015200795",
          "2024311",
          "3004369318",
          "3003477135",
          "3008988055",
          "3003335547",
          "3005160949",
          "3008514029",
          "3007616088",
          "3004593495",
          "3027063190",
          "3021836309",
          "3010326622",
          "3010086866",
          "3010531069",
          "3005210579",
          "3006705815"
        ],
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}