{
  "code": "DSY",
  "deviceName": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
  "deviceClass": "II",
  "regulationNumber": "870.3450",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 188,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 485,
    "last12Months": 95
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 188
  },
  "recalls": {
    "total": 86,
    "recent": [
      {
        "resNumber": "Z-1492-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vascutek, Ltd.",
        "firmAsPublished": "Vascutek, Ltd.",
        "reason": "Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.",
        "initiated": "2025-12-18"
      },
      {
        "resNumber": "Z-0036-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "W. L. Gore & Associates, Inc.",
        "firmAsPublished": "W L Gore & Associates, Inc.",
        "reason": "Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.",
        "initiated": "2025-08-26"
      },
      {
        "resNumber": "Z-1952-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Atrium Medical Corporation",
        "firmAsPublished": "Atrium Medical Corporation",
        "reason": "Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.",
        "initiated": "2024-05-03"
      },
      {
        "resNumber": "Z-1953-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Atrium Medical Corporation",
        "firmAsPublished": "Atrium Medical Corporation",
        "reason": "Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.",
        "initiated": "2024-05-03"
      },
      {
        "resNumber": "Z-1955-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Atrium Medical Corporation",
        "firmAsPublished": "Atrium Medical Corporation",
        "reason": "Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.",
        "initiated": "2024-05-03"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252445",
      "deviceName": "Fusion Bioline Vascular Graft",
      "applicant": "Maquet Cardiovascular, LLC",
      "company": "Maquet Cardiovascular, LLC",
      "decisionDate": "2026-04-27",
      "dateReceived": "2025-08-04"
    },
    {
      "kNumber": "K252277",
      "deviceName": "Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645)",
      "applicant": "Vascular Flow Technologies Limited",
      "company": "Vascular Flow Technologies Limited",
      "decisionDate": "2025-10-20",
      "dateReceived": "2025-07-22"
    },
    {
      "kNumber": "K241550",
      "deviceName": "Gelweave™ Vascular Prostheses",
      "applicant": "Vascutek, Ltd.",
      "company": "Vascutek, Ltd.",
      "decisionDate": "2025-02-27",
      "dateReceived": "2024-05-31"
    },
    {
      "kNumber": "K241070",
      "deviceName": "Gelsoft™ Plus Vascular Prostheses",
      "applicant": "Vascutek, Ltd.",
      "company": "Vascutek, Ltd.",
      "decisionDate": "2024-11-15",
      "dateReceived": "2024-04-19"
    },
    {
      "kNumber": "K231972",
      "deviceName": "Advanta VXT Vascular Graft, Flixene Vascular Graft",
      "applicant": "Atrium Medical Corporation",
      "company": "Atrium Medical Corporation",
      "decisionDate": "2024-03-28",
      "dateReceived": "2023-07-03"
    },
    {
      "kNumber": "K240083",
      "deviceName": "GORE® PROPATEN® Vascular Graft",
      "applicant": "W. L. Gore & Associates, Inc.",
      "company": "W. L. Gore & Associates, Inc.",
      "decisionDate": "2024-03-01",
      "dateReceived": "2024-01-11"
    },
    {
      "kNumber": "K233783",
      "deviceName": "exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts",
      "applicant": "Peca Labs, Inc.",
      "company": "Peca Labs, Inc.",
      "decisionDate": "2024-01-17",
      "dateReceived": "2023-11-27"
    },
    {
      "kNumber": "K232312",
      "deviceName": "GORE® PROPATEN® Vascular Graft",
      "applicant": "W. L. Gore & Associates, Inc.",
      "company": "W. L. Gore & Associates, Inc.",
      "decisionDate": "2024-01-09",
      "dateReceived": "2023-08-02"
    },
    {
      "kNumber": "K233551",
      "deviceName": "GORE® ACUSEAL Vascular Graft",
      "applicant": "W. L. Gore & Associates, Inc.",
      "company": "W. L. Gore & Associates, Inc.",
      "decisionDate": "2023-12-19",
      "dateReceived": "2023-11-03"
    },
    {
      "kNumber": "K231505",
      "deviceName": "GORE® ACUSEAL Vascular Graft",
      "applicant": "W. L. Gore & Associates, Inc.",
      "company": "W. L. Gore & Associates, Inc.",
      "decisionDate": "2023-06-23",
      "dateReceived": "2023-05-24"
    }
  ],
  "topApplicants": [
    {
      "name": "W. L. Gore & Associates, Inc.",
      "count": 23
    },
    {
      "name": "Vascutek, Ltd.",
      "count": 22
    },
    {
      "name": "Atrium Medical Corp.",
      "count": 16
    },
    {
      "name": "Meadox Medicals, Div. Boston Scientific Corp.",
      "count": 15
    },
    {
      "name": "Intervascular, Inc.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "W. L. Gore & Associates, Inc.",
      "count": 24,
      "spellings": 2
    },
    {
      "name": "Vascutek, Ltd.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Atrium Medical Corporation",
      "count": 18,
      "spellings": 2
    },
    {
      "name": "Intervascular, Inc.",
      "count": 17,
      "spellings": 3
    },
    {
      "name": "Meadox Medicals, Div. Boston Scientific Corp.",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 24,
        "expectedLow": 0,
        "expectedHigh": 22.37463511965092,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 24.91502138745346,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 24.496921436307883,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 24.981082978976485,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 20.893264746096236,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 33.98004580202535,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 48.81832575821647,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 35.98159768880322,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 34.56379669611236,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 32.61247049457173,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 31.15339663998411,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 34.74355082690751,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 38.083607986739736,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 28.69476765705359,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 29,
        "expectedLow": 0,
        "expectedHigh": 30.226936050536892,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1492-2026, Z-0036-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1492-2026",
          "Z-0036-2026"
        ],
        "severity": 75
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ADSY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADSY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADSY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADSY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADSY"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.681Z"
}