device derived

{
  "input": {
    "type": "http",
    "method": "GET",
    "queryParams": {
      "firm": "Medtronic"
    }
  },
  "output": {
    "type": "json",
    "example": {
      "query": {
        "firm": "Medtronic",
        "device": null
      },
      "counts": {
        "recalls": 1917,
        "clearances": 1585,
        "openRecalls": 8
      },
      "source": "openFDA — 510(k) clearances and device recall enforcement (US FDA)",
      "reasons": [
        "1585 510(k) clearance(s) on record, but 8 recall(s) are still open.",
        "Most recent open recall: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture i"
      ],
      "recalls": [
        {
          "action": "On 7/13/2026, field safety notices were sent to customers asking them to do the following:\n1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. \n2) Contact your Health…",
          "reason": "Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten…",
          "status": "Open, Classified",
          "product": "MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;",
          "postedOn": "2026-08-18",
          "quantity": "16",
          "rootCause": "Process design",
          "initiatedOn": "2026-07-13",
          "distribution": "International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.",
          "recallNumber": "Z-2980-2026",
          "terminatedOn": null,
          "recallingFirm": "Medtronic MiniMed, Inc.",
          "relatedClearances": [
            "K251032"
          ]
        },
        {
          "action": "On 7/13/2026, field safety notices were sent to customers asking them to do the following:\n1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. \n2) Contact your Health…",
          "reason": "Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten…",
          "status": "Open, Classified",
          "product": "MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;",
          "postedOn": "2026-08-18",
          "quantity": "7",
          "rootCause": "Process design",
          "initiatedOn": "2026-07-13",
          "distribution": "International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.",
          "recallNumber": "Z-2981-2026",
          "terminatedOn": null,
          "recallingFirm": "Medtronic MiniMed, Inc.",
          "relatedClearances": []
        }
      ],
      "verdict": "CLEARED_WITH_OPEN_RECALL",
      "clearances": [
        {
          "kNumber": "K262735",
          "decision": "Substantially Equivalent",
          "location": "Mounds View, MN, US",
          "applicant": "Medtronic, Inc.",
          "decidedOn": "2026-08-28",
          "deviceName": "LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)",
          "receivedOn": "2026-07-31",
          "productCode": "MXD",
          "advisoryPanel": "Cardiovascular",
          "clearanceType": "Special"
        },
        {
          "kNumber": "K262005",
          "decision": "Substantially Equivalent",
          "location": "Mounds View, MN, US",
          "applicant": "Medtronic, Inc.",
          "decidedOn": "2026-08-21",
          "deviceName": "Affera Integrated Mapping System",
          "receivedOn": "2026-06-15",
          "productCode": "DQK",
          "advisoryPanel": "Cardiovascular",
          "clearanceType": "Special"
        }
      ],
      "disclaimer": "Advisory only, provided as is without warranty of accuracy or completeness. Absence of a 510(k) record is not proof a device is uncleared — exempt and PMA-approved devices are not in this dataset. Not…",
      "retrievedAt": "2026-09-09T00:53:40.644Z"
    }
  }
}