{
  "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": "163813",
      "product_res_number": "Z-2471-2018",
      "event_date_initiated": "2018-04-23",
      "event_date_created": "2018-07-18",
      "recall_status": "Open, Classified",
      "res_event_number": "79887",
      "product_code": "OYC",
      "pma_numbers": [
        "P140015"
      ],
      "product_description": "t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM\n\nSoftware version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.",
      "code_info": "Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 501200, 501202,\t\t 501205,\t\t 501207,\t\t 501268,\t\t 501285,\t\t 501364,\t\t 501368,\t\t 501370,\t\t 501376,\t\t 501385,\t\t 501386,\t\t 501387,\t\t 501432, 501435, 501440, 501443, 501444, 501445, 501466, 501479, 501488, 501490, 501491, 501495, 501503, 501508, 501509, 501519, 501522, 501523, 501526, 501535, 501560, 504522, 504531, 504535, 504540,\t 504753,\t 504972,\t 504990,\t 505025,\t 90472671,\t 90488584",
      "firm_fei_number": "3007981285",
      "recalling_firm": "Tandem Diabetes Care Inc",
      "address_1": "11075 Roselle St Ste 200 11075 Roselle St",
      "address_2": "Ste 200",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-1231",
      "reason_for_recall": "The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: \nA) by triggering a Malfunction 4 Alarm, or \nB) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.",
      "root_cause_description": "Device Design",
      "action": "On 04/23/2018, customers were sent Urgent Medical Device Voluntary Recall letters via overnight mail delivery and email. The letter instructed customers to call Customer Support at 1-877-801-6901 to arrange for replacement pumps. Customers were advised to continue using effected devices provided they kept Emergency Kits with backup insulin supplies with them. If customers noted unexpected battery behavior, malfunction 4 alarm, or the following alerts: Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low), then customers were advised to discontinue use and use backup insulin supplies, while they waited for replacement pumps. The firm advised customers to fill out and return via fax, email, or mail Medical Device Recall Return Response forms.",
      "product_quantity": "55",
      "distribution_pattern": "U.S. Consignees: IN, AZ, UT, TX, NY, NJ, MD, MN, IL, CO, AL, WI,   CA, PA, OH, OR, MS, FL, NM, ID, NV, KY, VA,",
      "openfda": {
        "pma_number": [
          "P130007",
          "P140015"
        ],
        "registration_number": [
          "2032227",
          "3013756811",
          "3042027705",
          "2030598",
          "3007981285",
          "2134850"
        ],
        "fei_number": [
          "3013756811",
          "3042027705",
          "3003166194",
          "1000518731",
          "3003007876",
          "3007981285"
        ],
        "device_name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}