PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
type: Dataset
description: FDA recall Z-0479-2024 — Heartware, Inc. is recalling PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 (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.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
  type: MedicalDevice
  manufacturer: Heartware, Inc.
claims: FDA recall Z-0479-2024: Heartware, Inc. is recalling PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
claims: FDA classified recall Z-0479-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0479-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0479-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Heartware, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-10-31
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN none, Serial Numbers: HW10001, HW10002, HW10003, HW10004, HW10005, HW10006, HW10007, HW10008, HW10009, HW10010, HW10011, HW10012, HW10013, HW10014, HW10015, HW10016, HW10017, HW10018, HW10019, HW10020, HW10021, HW10022, HW10023, HW10024, HW10025, HW10026, HW10027, HW10028, HW10029, HW10030, HW10031, HW10032, HW10033, HW10034, HW10035, HW10036, HW10037, HW10038, HW10039, HW10040, HW10041, HW10042, HW10043, HW10044, HW10045, HW10046, HW10047, HW10048, HW10049, HW10050, HW10051, HW10052, HW10053, HW10055, HW10056, HW10057, HW10058, HW10059, HW10060, HW10061, HW10062, HW10063, HW10064, HW10065, HW10066, HW10067, HW10068, HW10070, HW10071, HW10072, HW10073, HW10074, HW10075, HW10076, HW10077, HW10079, HW10080, HW10081, HW10082, HW10083, HW10084, HW10085, HW10086, HW10087, HW10088, HW10089, HW10090, HW10091, HW10092, HW10093, HW10094, HW10095, HW10096, HW10097, HW10098, HW10099, HW10100, HW10101, HW10102, HW10103, HW10104, HW10105, HW10106, HW10107, HW10108, HW10109, HW10110, HW10111, HW10112, HW10113, HW10114, HW10115, HW10116, HW10117, HW10118, HW10119, HW10120, HW10121, HW10122, HW10123, HW10124, HW10125, HW10126, HW10127, HW10128, HW10129, HW10130, HW10131, HW10132, HW10133, HW10135, HW10136, HW10137, HW10138, HW10139, HW10140, HW10141, HW10142, HW10143, HW10144, HW10145, HW10146, HW10147, HW10148, HW10149, HW10150, HW10151, HW10152, HW10153, HW10154, HW10155, HW10156, HW10157, HW10158, HW10159, HW10160, HW10161, HW10162, HW10163, HW10164, HW10165, HW10166, HW10167, HW10168, HW10169, HW10170, HW10171, HW10172, HW10173, HW10174, HW10175, HW10176, HW10177, hw10178, HW10179, HW10180, HW10181, HW10182, HW10183, HW10184, HW10185, HW10186, HW10187, HW10188, HW10189, HW10190, HW10191, HW10192, HW10193, HW10194, HW10195, HW10196, HW10197, HW10198, HW10200, HW10201, HW10202, HW10203, HW10204, HW10205, HW10206, HW10207, HW10209, HW10210, HW10211, HW10212, HW10213, HW10214, HW10215, HW10216, HW10217, HW10218, HW10219, HW10220, HW10221, HW10222, hw10223, HW10224, HW10225, HW…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0479-2024: Heartware, Inc. is recalling PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
type: Claim
text: The FDA logged enforcement record Z-0479-2024: Heartware, Inc. is voluntarily recalling PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 — reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-31. Affected lots/codes: GTIN none, Serial Numbers: HW10001, HW10002, HW10003, HW10004, HW10005, HW10006, HW10007, HW10008, HW10009, HW10010, HW10011, HW10012, HW10013, HW10014, HW10015, HW10016, HW10017, HW10018, HW10019, HW10020, HW10021, HW10022, HW10023, HW10024, HW10025, HW10026, HW10027, HW10028, HW10029, HW10030, HW10031, HW10032, HW10033, HW10034, HW10035, HW10036, HW10037, HW10038, HW10039, HW10040, HW10041, HW10042, HW10043, HW10044, HW10045, HW10046, HW10047, HW10048, HW10049, HW10050, HW10051, HW10052, HW10053, HW10055, HW10056, HW10057, HW10058, HW10059, HW10060, HW10061, HW10062, HW10063, HW10064, HW10065, HW10066, HW10067, HW10068, HW10070, HW10071, HW10072, HW10073, HW10074, HW10075, HW10076, HW10077, HW10079, HW10080, HW10081, HW10082, HW10083, HW10084, HW10085, HW10086, HW10087, HW10088, HW10089, HW10090, HW10091, HW10092, HW10093, HW10094, HW10095, HW10096, HW10097, HW10098, HW10099, HW10100, HW10101, HW10102, HW10103, HW10104, HW10105, HW10106, HW10107, HW10108, HW10109, HW10110, HW10111, HW10112, HW10113, HW10114, HW10115, HW10116, HW10117, HW10118, HW10119, HW10120, HW10121, HW10122, HW10123, HW10124, HW10125, HW10126, HW10127, HW10128, HW10129, HW10130, HW10131, HW10132, HW10133, HW10135, HW10136, HW10137, HW10138, HW10139, HW10140, HW10141, HW10142, HW10143, HW10144, HW10145, HW10146, HW10147, HW10148, HW10149, HW10150, HW10151, HW10152, HW10153, HW10154, HW10155, HW10156, H…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-0479-2024 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.