PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
type: Dataset
description: FDA recall Z-0478-2024 — Heartware, Inc. is recalling PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 (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 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
  type: MedicalDevice
  manufacturer: Heartware, Inc.
claims: FDA recall Z-0478-2024: Heartware, Inc. is recalling PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
claims: FDA classified recall Z-0478-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0478-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0478-2024
      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: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046, HW11047, HW11050, HW11051, HW11052, HW11053, HW11054, HW11057, HW11060, HW11061, HW11062, HW11063, HW11064, HW11065, HW11067, HW11070, HW11071, HW11072, HW11074, HW11075, HW11076, HW11077, HW11078, HW11082, HW11083, HW11085, HW11086, HW11087, HW11088, HW11089, HW11091, HW11092, HW11093, HW11094, HW11096, HW11100, HW11101, HW11103, HW11105, HW11106, HW11107, HW11109, HW11111, HW11112, HW11113, HW11114, HW11116, HW11117, HW11118, HW11119, HW11120, HW11121, HW11122, HW11123, HW11125, HW11126, HW11129, HW11130, HW11133, HW11134, HW11137, HW11138, HW11139, HW11140, HW11141, HW11142, HW11146, HW11147, HW11148, HW11149, HW11150, HW11151, HW11152, HW11153, HW11155, HW11157, HW11160, HW11161, HW11164, HW11165, HW11166, HW11168, HW11171, HW11172, HW11173, HW11174, HW11176, HW11177, HW11178, HW11180, HW11181, HW11183, HW11184, HW11185, HW11186, HW11187, HW11188, HW11190, HW11191, HW11192, HW11193, HW11194, HW11195, HW11196, HW11197, HW11198, HW11199, HW11201, HW11202, HW11204, HW11205, HW11209, HW11210, HW11216, HW11217, HW11218, HW11219, HW11221, HW11222, HW11223, HW11224, HW11225, HW11227, HW11228, HW11229, HW11230, HW11231, HW11232, HW11233, HW11234, HW11235, HW11236, HW11239, HW11240, HW11241, HW11242, HW11244, HW11246, HW11247, HW11248, HW11250, HW11251, HW11252, HW11255, HW11256, HW11257, HW11258, HW11259, HW11260, HW11262, HW11263, HW11264, HW11266, HW11267, HW11269, HW11271, HW11272, HW11274, HW11275, HW11276, HW11277, HW11279, HW11280, HW11281, HW11283, HW11284, HW11286, HW11287, HW11288, HW11289, HW11290, HW11291, HW11292, HW11293, HW11294, HW11295, hw11296, HW11298, HW11299, HW11302, HW11303, HW11305, HW11306, HW11307, HW11309, HW11310, HW11311, HW11312, HW11313, HW11314, HW11316, HW11317, HW11318, HW11319, HW11320, HW11321, HW…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0478-2024: Heartware, Inc. is recalling PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
type: Claim
text: The FDA logged enforcement record Z-0478-2024: Heartware, Inc. is voluntarily recalling PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 — 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: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046, HW11047, HW11050, HW11051, HW11052, HW11053, HW11054, HW11057, HW11060, HW11061, HW11062, HW11063, HW11064, HW11065, HW11067, HW11070, HW11071, HW11072, HW11074, HW11075, HW11076, HW11077, HW11078, HW11082, HW11083, HW11085, HW11086, HW11087, HW11088, HW11089, HW11091, HW11092, HW11093, HW11094, HW11096, HW11100, HW11101, HW11103, HW11105, HW11106, HW11107, HW11109, HW11111, HW11112, HW11113, HW11114, HW11116, HW11117, HW11118, HW11119, HW11120, HW11121, HW11122, HW11123, HW11125, HW11126, HW11129, HW11130, HW11133, HW11134, HW11137, HW11138, HW11139, HW11140, HW11141, HW11142, HW11146, HW11147, HW11148, HW11149, HW11150, HW11151, HW11152, HW11153, HW11155, HW11157, HW11160, HW11161, HW11164, HW11165, HW11166, HW11168, HW11171, HW11172, HW11173, HW11174, HW11176, HW11177, HW11178, HW11180, HW11181, HW11183, HW11184, HW11185, HW11186, HW11187, HW11188, HW11190, HW11191, HW11192, HW11193, HW11194, HW11195, HW11196, HW11197, HW11198, HW11199, HW11201, HW11202, HW11204, HW11205, HW11209, HW11210, HW11216, HW11217, HW11218, HW11219, HW11221, HW11222, HW11223, HW11224, HW11225, HW11227, HW11228, HW11229, HW11230, HW11231, HW11232, HW11233, 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-0478-2024 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.