# FDA recall Z-0476-2024

> **Heartware, Inc.** · Class II · device recall initiated 2023-10-31.

## Product

STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101

## Reason for recall

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

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0476-2024
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-31
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2024

## Citation

> AI Analytics. FDA recall Z-0476-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0476-2024. Source: US FDA. Licensed CC0.

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