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  "name": "CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.",
  "description": "FDA recall Z-1219-2023 — St. Jude Medical is recalling CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.",
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      "name": "St. Jude Medical"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1219-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1219-2023: St. Jude Medical is recalling CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.",
      "text": "The FDA logged enforcement record Z-1219-2023: St. Jude Medical is voluntarily recalling CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. — reason: Radiated Radiofrequency (RF) emissions of the  CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-07. Affected lots/codes: UDI/DI 05414734509176, Serial Numbers: M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M140300449, M140300450, M140300451, M140300454, M140300458, M140300459, M140300460, M140300463, M140500480, M140500486, M140800987, M140800988, M140800992, M140800995, M140801002, M140801003, M140801004, M140801007, M140801010, M140801011, M141001528, M141001529, M141001530, M141001531, M141001536, M141001539, M141001541, M141001544, M141001545, M141001546, M141101678, M141101681, M141101682, M141101683, M141101684, M141101685, M141101686, M141101693, M141101696, M141101697, M141101700, M141101701, M141101703, M141101705, M141101706, M150102038, M150102039, M150102049, M150102052, M150102054, M150102055, M150102059, M150102061, M150102062, M150102064, M150102066, M150102399, M150102402, M150102404, M150102409, M150102410, M150102414, M150102416, M150202537, M150202538, M150202541, M150202542, M150202544, M150202545, M150302658, M150302660, M150302662, M150302664, M150302666, M150302667, M150302669, M150302673, M150302680, M150302682, M150302683, M150302687, M150302689, M150302690, M150302692, M150302694, M150302695, M150302702, M150302703, M150302707, M150302711, M150302712, M150302713, M150302716, M150302721, M150302723, M150302724, M150302725, M150302729, M150302737, M150302739, M150302742, M150302747, M150302748, M150302751, M150302755, M150302757, M150302758, M150302759, M150302762, M150302769, M150302773, M150302777, M150302778, M150302779, M150302780, M150302782, M150302783, M150302786, M150403048, M150403050, M150403051, M150403057, M150403066, M150805139, M150805143, M150805151, M150805154, M150805155, M150805156, M150805158, M150805160, M150805161, M150805162, M150805166, M150905677, M150905680, M150905682, M150905683, M150905685, M150905688, M150905689, M150905691, M150905692, M150905697, M150905698, M150905699, M150905702, M150905703, M150905704, M150905706, M150905707, M150905708, M150905709, M150905711, M150905714, M151206628, M151206631, M151206633, M151206636, M151206637, M151206641, M151206644, M151206645, M151206647, M151206648, M151206651, M151206655, M151206659, M151206662, M151206665, M160206849, M160206853, M160206854, M160206857, M160206861, M160206867, M160206869, M160206872, M160206876, M160206879, M160206880, M160206882, M160206885, M160206888, M160206896, M160206899, M160206900, M160206902, M160206903, M160206906, M160807699, M160807700, M160807701, M160807772.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1219-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1219-2023/fda-classification",
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      "name": "FDA classified recall Z-1219-2023 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "supported": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1219-2023&lang=eng"
        }
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1219-2023/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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      "name": "FDA recall details — Z-1219-2023",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "St. Jude Medical",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Radiated Radiofrequency (RF) emissions of the  CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-02-07",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI/DI 05414734509176, Serial Numbers: M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M140300449, M140300450, M140300451, M140300454, M140300458, M140300459, M140300460, M140300463, M140500480, M140500486, M140800987, M140800988, M140800992, M140800995, M140801002, M140801003, M140801004, M140801007, M140801010, M140801011, M141001528, M141001529, M141001530, M141001531, M141001536, M141001539, M141001541, M141001544, M141001545, M141001546, M141101678, M141101681, M141101682, M141101683, M141101684, M141101685, M141101686, M141101693, M141101696, M141101697, M141101700, M141101701, M141101703, M141101705, M141101706, M150102038, M150102039, M150102049, M150102052, M150102054, M150102055, M150102059, M150102061, M150102062, M150102064, M150102066, M150102399, M150102402, M150102404, M150102409, M150102410, M150102414, M150102416, M150202537, M150202538, M150202541, M150202542, M150202544, M150202545, M150302658, M150302660, M150302662, M150302664, M150302666, M150302667, M150302669, M150302673, M150302680, M150302682, M150302683, M150302687, M150302689, M150302690, M150302692, M150302694, M150302695, M150302702, M150302703, M150302707, M150302711, M150302712, M150302713, M150302716, M150302721, M150302723, M150302724, M150302725, M150302729, M150302737, M150302739, M150302742, M150302747, M150302748, M150302751, M150302755, M150302757, M150302758, M150302759, M150302762, M150302769, M150302773, M150302777, M150302778, M150302779, M150302780, M150302782, M150302783, M150302786, M150403048, M150403050, M150403051, M150403057, M150403066, M150805139, M150805143, M150805151, M150805154, M150805155, M150805156, M150805158, M150805160, M150805161, M150805162, M150805166, M150905677, M150905680, M150905682, M150905683, M150905685, M150905688, M150905689, M150905691, M150905692, M150905697, M150905698, M150905699, M150905702, M150905703, M150905704, M150905706, M150905707, M150905708, M150905709, M150905711, M150905714, M151206628, M151206631, M151206633, M151206636, M151206637, M151206641, M151206644, M151206645, M151206647, M151206648, M151206651, M151206655, M151206659, M151206662, M151206665, M160206849, M160206853, M160206854, M160206857, M160206861, M160206867, M160206869, M160206872, M160206876, M160206879, M160206880, M160206882, M160206885, M160206888, M160206896, M160206899, M160206900, M160206902, M160206903, M160206906, M160807699, M160807700, M160807701, M160807772.",
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.",
            "Status": "recorded"
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