{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82626",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "address_2": "N/A",
      "postal_code": "55432-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands",
      "recall_number": "Z-1774-2019",
      "product_description": "InterStim(TM) System, Model Numbers:  a) TH90G01  b) TH90GFA  c) TH90G02  d) TH90G03    Product Usage:  The 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\u001d 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).",
      "product_quantity": "13979 units",
      "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).",
      "recall_initiation_date": "20190515",
      "center_classification_date": "20190612",
      "report_date": "20190619",
      "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"
    }
  ]
}