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  "name": "Burr Hole Cover Kit, REF: M365DB4600C0;  Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual",
  "description": "FDA recall Z-2340-2025 — Boston Scientific Neuromodulation Corporation is recalling Burr Hole Cover Kit, REF: M365DB4600C0;  Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual (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": "Burr Hole Cover Kit, REF: M365DB4600C0;  Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual",
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      "name": "Boston Scientific Neuromodulation Corporation"
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      "name": "FDA recall Z-2340-2025: Boston Scientific Neuromodulation Corporation is recalling Burr Hole Cover Kit, REF: M365DB4600C0;  Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual",
      "text": "The FDA logged enforcement record Z-2340-2025: Boston Scientific Neuromodulation Corporation is voluntarily recalling Burr Hole Cover Kit, REF: M365DB4600C0;  Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual — reason: Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-08. Affected lots/codes: All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802,  M365DB4605C0/08714729820819. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2340-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2340-2025&lang=eng"
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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-2340-2025/fda-classification",
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      "name": "FDA classified recall Z-2340-2025 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2340-2025/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "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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            "Field": "Reason",
            "Value": "Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.",
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            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, T¿rkiye, UAE, Ukraine, United Kingdom, Canada, Japan, Argentina, Brazil, Chile, Colombia , Ecuador, Mexico, Hong Kong, China, India, Singapore, Korea, Taiwan.",
            "Status": "recorded"
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