{
  "format": "devicerts.device.v1",
  "cite_as": "6177, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/na-6177 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/na-6177",
    "json_url": "https://devicerts.com/devices/na-6177.json",
    "markdown_url": "https://devicerts.com/devices/na-6177.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/na-6177",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "6177",
    "registry_name": "6177",
    "url": "https://devicerts.com/devices/na-6177",
    "manufacturer": {
      "name": "Medtronic, Inc.",
      "url": "https://devicerts.com/manufacturers/medtronic-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00681490142656",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "PMA number",
        "values": [
          {
            "value": "P890003",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "OSR",
      "KRG",
      "DXY"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "58968",
        "term": "Instrument management bag"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00681490142656",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2014-09-23",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA PMA",
      "number": "P890003",
      "number_label": null,
      "device_udi_di": null,
      "date": "1998-08-12",
      "date_kind": "decision",
      "decision_code": "APPR",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0303-2027",
      "classification": "",
      "status": "ongoing",
      "initiated": "2026-09-24",
      "reason": "Software problem has the potential for an inaccurate displayed longevity estimate.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-0304-2027",
      "classification": "",
      "status": "ongoing",
      "initiated": "2026-09-24",
      "reason": "Software problem has the potential for an inaccurate displayed longevity estimate.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-0302-2027",
      "classification": "",
      "status": "ongoing",
      "initiated": "2026-09-24",
      "reason": "Software problem has the potential for an inaccurate displayed longevity estimate.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-2168-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-06-18",
      "reason": "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-2169-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-06-18",
      "reason": "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-2127-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-06-17",
      "reason": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available.  The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.",
      "applies": "this device",
      "via": "P890003"
    },
    {
      "number": "Z-2128-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-06-17",
      "reason": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available.  The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.",
      "applies": "this device",
      "via": "P890003"
    },
    {
      "number": "Z-2506-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2020-06-04",
      "reason": "There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management\", Atrial Lead Position Check\", EffectivCRT\" algorithms, and AdaptivCRT\").  This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-2505-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2020-06-04",
      "reason": "There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management\", Atrial Lead Position Check\", EffectivCRT\" algorithms, and AdaptivCRT\").  This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-0845-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-01-17",
      "reason": "There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer.  A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.",
      "applies": "this device",
      "via": "P890003"
    },
    {
      "number": "Z-0399-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-07-14",
      "reason": "Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices.  Potential impacts could lead to missed CareAlert notifications or device reports.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-0400-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-07-14",
      "reason": "Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices.  Potential impacts could lead to missed CareAlert notifications or device reports.",
      "applies": "shared submission",
      "via": "P890003"
    },
    {
      "number": "Z-2209-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-06-11",
      "reason": "Medtronic has identified that a subset  of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a \"ticking sound\" and they were unable to transmit device data via CareLink.  These monitors are now non-functional. \nNo patient injuries have been reported as a result of this issue.",
      "applies": "shared submission",
      "via": "P890003"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
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            {
              "value": "Instrument management bag",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Model / reference",
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          "label": "Device class",
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    {
      "group": "Dimensions & Sizes",
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        {
          "label": "Size",
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            {
              "value": "Length — 120.0 Inch",
              "registries": [
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          "label": "Supplied sterile",
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          "label": "Contains latex",
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}