{
  "companyId": "55616",
  "slug": "st-jude-medical-inc-55616",
  "name": "St. Jude Medical, Inc.",
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    "total": 128,
    "last12Months": 0,
    "first": "1989-09-26",
    "latest": "2018-07-20"
  },
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  "productCodeCount": 26,
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    "openLast12Months": 0,
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      {
        "resNumber": "Z-1427-2025",
        "productCode": "MOM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-02-03",
        "reason": "Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing."
      },
      {
        "resNumber": "Z-0987-2025",
        "productCode": "MOM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-11-06",
        "reason": "Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings."
      },
      {
        "resNumber": "Z-0988-2025",
        "productCode": "MOM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-10-05",
        "reason": "As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings."
      },
      {
        "resNumber": "Z-0989-2025",
        "productCode": "MOM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-10-05",
        "reason": "As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings."
      },
      {
        "resNumber": "Z-2348-2024",
        "productCode": "DYB",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-04-30",
        "reason": "One lot of product has dilators that are too short and will not extend outside the introducer sheath."
      }
    ]
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    "countries": [
      "US"
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      "code": "DYB",
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      "latest": "2016-05-19",
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    },
    {
      "code": "DQK",
      "deviceName": "Computer, Diagnostic, Programmable",
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      "latest": "2018-04-23",
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    },
    {
      "code": "DRF",
      "deviceName": "Catheter, Electrode Recording, Or Probe, Electrode Recording",
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    {
      "code": "DQY",
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    },
    {
      "code": "KRH",
      "deviceName": "Ring, Annuloplasty",
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      "latest": "2009-10-16",
      "medianReviewDays": 30
    },
    {
      "code": "MXC",
      "deviceName": "Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)",
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      "medianReviewDays": 92
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
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      "latest": "2014-11-13",
      "medianReviewDays": 47
    },
    {
      "code": "GZB",
      "deviceName": "Stimulator, Spinal-Cord, Implanted (Pain Relief)",
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    },
    {
      "code": "KFM",
      "deviceName": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
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    },
    {
      "code": "DQO",
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    },
    {
      "code": "DRA",
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    },
    {
      "code": "DRC",
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      "medianReviewDays": 28
    },
    {
      "code": "DXO",
      "deviceName": "Transducer, Pressure, Catheter Tip",
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      "latest": "2016-08-15",
      "medianReviewDays": 88
    },
    {
      "code": "GXR",
      "deviceName": "Cover, Burr Hole",
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      "latest": "2018-07-20",
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    },
    {
      "code": "LDF",
      "deviceName": "Electrode, Pacemaker, Temporary",
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    {
      "code": "LLZ",
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    {
      "code": "MTD",
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    {
      "code": "NFA",
      "deviceName": "Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection",
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    {
      "code": "OCL",
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      "latest": "2008-09-16",
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    },
    {
      "code": "DRB",
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    {
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    {
      "code": "DXJ",
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    {
      "code": "IYO",
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    {
      "code": "KRA",
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      "kNumber": "K181382",
      "deviceName": "GuardianTM Burr Hole Cover System",
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    },
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        "method": "normalised"
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22St.%20Jude%20Medical%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22St.%20Jude%20Medical%2C%20Inc.%22"
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  "retrievedAt": "2026-08-11T14:48:53.036Z"
}