{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210582",
      "product_res_number": "Z-0551-2025",
      "event_date_initiated": "2024-10-01",
      "event_date_posted": "2024-11-26",
      "recall_status": "Open, Classified",
      "res_event_number": "95557",
      "product_code": "NVZ",
      "pma_numbers": [
        "P910023S191"
      ],
      "product_description": "Merlin@home Transmitter REF EX1100\n\nThe Merlin@home\" (M@h) transmitter is intended to transfer stored data from\nthe patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)\nto facilitate remote monitoring by using inductive (EX1100 Model) or RF\ntelemetry (EX1150 Model) to read device data and transmitting to the Merlin.net\nPCN server.",
      "code_info": "Model Number: EX1100\nUDI-DI code: Pending\nSerial Numbers:\n12600224\n12600307\n12600895\n12600974\n12601074\n12601156\n12601169\n12602176\n12602216\n12602464\n12602491\n12604265\n12604852\n12606254\n12606332\n12606531\n12606550\n12606551\n12606587\n12606785\n12606814\n12607289\n12607557\n12608093\n12608346\n12608623\n12608678\n12608758\n12608819\n12609094\n12609148\n12609819\n12609919\n12610472\n12610550\n12611493\n12611733\n12611975\n12612409\n12612417\n12612541\n12612929\n12613146\n12613636\n12617342\n12617350\n12617583\n12617821\n12618054\n12618130\n12618726\n12618782\n12619218\n12619405\n12619515\n12619825\n12619827\n12620745\n12621171\n12622233\n12622283\n12622473\n12623904\n12625575\n12625701\n12625874\n12628403\n12628624\n12628626\n12634096\n12634120\n12634141\n12634152\n12634208\n12635184\n12635287\n12636062\n12636067\n12636127\n12636195\n12638900\n12639020\n12640950\n12641103\n12641819\n12643036\n12643543\n12643551\n12643589\n12643621\n12643623\n12643640\n12643744\n12643781\n12643792\n12647278\n12647327\n12647343\n12647350\n12647621\n12647781\n12647787\n12647789\n12647904\n12647923\n12647939\n12647940\n12648513\n12648520\n12648589\n12648611\n12648704\n12648839\n12649443\n12649481\n12649517\n12650938\n12651018\n12651022\n12651051\n12651056\n12651073\n12651198\n12651419\n12651476\n12651597\n12652036\n12652060\n12652070\n12652076",
      "firm_fei_number": "2017865",
      "recalling_firm": "Abbott Medical",
      "address_1": "15900 Valley View Ct",
      "city": "Sylmar",
      "state": "CA",
      "postal_code": "91342-3577",
      "additional_info_contact": "Alicia Swanson,\n408-845-3427",
      "reason_for_recall": "Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.",
      "root_cause_description": "Software design",
      "action": "On 10/25/2024, the firm initiated notifying customers in person/verbally regarding a limited number of Merlin@home Transmitters with MerlinOnDemand Capability that are unable to upgrade to the latest version of software.  This issue was caused by a power interruption during a past software updated attempt.\n\nAbbott will be retrieving and replacing the affected Transmitters.  The replacement Transmitter will have the latest software update version 9.0rev1\n\nFor questions or further assistance, speak with or contact the Abbott representative that is on-site replacing the Transmitter, or contact the Public Contact at 408-845-3427",
      "product_quantity": "130 transmitters",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.",
      "openfda": {
        "pma_number": [
          "P930022",
          "P830045",
          "P880038",
          "P890003",
          "P960013",
          "P910023",
          "P950037",
          "P880006",
          "P950029",
          "P980035",
          "P010031",
          "P010015",
          "P900070",
          "P970012",
          "P990001",
          "P880086"
        ],
        "registration_number": [
          "3018094310",
          "2649622",
          "3013500228",
          "9614453",
          "9610139",
          "1028232",
          "1000165971",
          "3012552532",
          "3013288201",
          "3008483389",
          "3004593495",
          "3003120897",
          "3005334138",
          "2182208",
          "2030624",
          "3009144177",
          "3008159616",
          "2024024",
          "3015453963",
          "3002806603",
          "3011120183",
          "2133641",
          "3009380063",
          "2032521",
          "3008973940",
          "3005941719",
          "2017865",
          "3013596024",
          "3006705815",
          "3033257494",
          "1220452",
          "3008494315",
          "2135338",
          "2124215",
          "3004209178"
        ],
        "fei_number": [
          "3018094310",
          "3000203466",
          "2649622",
          "3013500228",
          "1028232",
          "3003574398",
          "3002807576",
          "1000165971",
          "3012552532",
          "3013288201",
          "3008483389",
          "3008377825",
          "3004593495",
          "3003120897",
          "3005334138",
          "2182208",
          "3009144177",
          "3000206435",
          "3008159616",
          "2024024",
          "3015453963",
          "3002806603",
          "3011120183",
          "3004369318",
          "3002807111",
          "3009380063",
          "3008973940",
          "2017865",
          "3013596024",
          "3006705815",
          "3033257494",
          "1220452",
          "3002806500",
          "3005700659",
          "2124215"
        ],
        "device_name": "Pulse Generator, Permanent, Implantable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}