---
title: "HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... — FDA record Z-0482-2024 | 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-0482-2024-hvad-heartware-ventricular-assist-device-sterile-implant-kit-implant-kit-ous-model-number-1205/
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/IMPLANT KIT OUS, Model Number 1205 — FDA record Z-0482-2024

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/IMPLANT KIT OUS, Model Number 1205
- **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**: 126 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0482-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0482-2024%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: HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028 |

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-0482-2024%22)

## Related records

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