{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "172112",
      "product_res_number": "Z-1774-2019",
      "event_date_initiated": "2019-05-15",
      "event_date_posted": "2019-06-07",
      "recall_status": "Open, Classified",
      "res_event_number": "82626",
      "product_code": "EZW",
      "pma_numbers": [
        "P970004S268",
        "P080025S163"
      ],
      "product_description": "InterStim(TM) System, Model Numbers:\na) TH90G01\nb) TH90GFA\nc) TH90G02\nd) TH90G03\n\nProduct Usage:\nThe Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).",
      "code_info": "Model Numbers/UDI: a) TH90G01/00763000058005  b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273,  00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310  ALL LOT/SERIAL NUMBERS",
      "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": "Medtronic Technical Services\n800-707-0933",
      "reason_for_recall": "There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).",
      "root_cause_description": "Software design",
      "action": "Medtronic sent an Urgent Medical Device Safety Notification letter dated May 2019, to US Physicians and European physician.  The notifications were delivered by mail, personal delivery by Medtronic Representatives, fax, or equivalent method.  A confirmation form will be used to document receipt and understanding of the notification, and a minimum three attempts will be made to obtain confirmation from non-responding physicians that the notification has been received and understood.",
      "product_quantity": "13979 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands",
      "openfda": {
        "pma_number": [
          "P970004",
          "P170001",
          "P240031",
          "P180046"
        ],
        "registration_number": [
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        "fei_number": [
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          "3009183442",
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        ],
        "device_name": "Stimulator, Electrical, Implantable, For Incontinence",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5270",
        "device_class": "3"
      }
    }
  ]
}