---
title: "HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... — FDA record Z-0475-2024 | Is It on Recall"
description: "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 HVA"
url: https://isitonrecall.com/recall/fda-device-z-0475-2024-hvad-heartware-ventricular-assist-device-sterile-implant-kit-model-number-1100/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 — FDA record Z-0475-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
- **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
- **Classification**: Class II
- **Recalling firm**: Heartware, Inc.
- **Quantity**: 45 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0475-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0475-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial numbers: HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW104, HW105, HW108, HW109, HW110, HW114, HW115, HW116, HW119, HW126, HW127, HW129, HW130, HW131, HW138, HW139, HW143, HW146, HW147, HW153, HW156, HW161, HW170, HW181 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 13, 2023
- **Recall initiation date**: Oct 31, 2023
- **Center classification date**: Dec 1, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0475-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Heartware, Inc. records](https://isitonrecall.com/brand/heartware-inc/)