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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0508-2026.jsonld",
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  "name": "Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit",
  "description": "FDA recall Z-0508-2026 — Thoratec LLC is recalling Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0508-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Thoratec LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0508-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0508-2026: Thoratec LLC is recalling Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit",
      "text": "The FDA logged enforcement record Z-0508-2026: Thoratec LLC is voluntarily recalling Brand Name: HeartMate  Product Name: HeartMate II¿ Controller (standalone)  Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller  Software Version: N/A  Product Description: The HeartMate II System Controller is a small computer that controls and monitors system  operation. It sends power and operating signals to the Left Ventricular Assist Device and  adjusts device operation to maintain programmed levels of cardiac support. The System  Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records  device performance and alarm data, and transfers the information to the HeartMate Touch  Communication System.  Component: Yes, HeartMate II¿ LVAS Implant Kit — reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-09. Affected lots/codes: Lot Code: All units of the following models are impacted: Model 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 00813024011996  Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.. A RECORDED FDA enforcement action (occurred=true).",
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        "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0508-2026/fda-classification",
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      "name": "FDA classified recall Z-0508-2026 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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      "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."
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      "@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.",
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      "reviewStatus": "current",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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-0508-2026",
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            "Value": "Z-0508-2026",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Thoratec LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-10-09",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Lot Code: All units of the following models are impacted: Model 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 00813024011996  Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.",
            "Status": "recorded"
          }
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