# FDA recall Z-1107-2022

> **Heartware, Inc.** · Class II · device recall initiated 2022-03-30.

## Product

HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:	  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Instructions For Use (FI)  HVAD¿ System Instructions For Use (FI)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Instructions For Use - FI  HVAD¿ System Instructions For Use (FI)  HVAD¿ System OUS Patient Manual (FI-Finnish)  HVAD¿ System Emergency Responder Guide (TR-Turkish)  HVAD¿ System Patient Manual (TR-Turkish)  HVAD¿ System Patient Manual (TR-Tu

## Reason for recall

Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

## Distribution

Finland and Turkey

## Key facts

- **Recall number:** Z-1107-2022
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-30
- **Report date:** 2022-05-25

- **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-1107-2022

## Citation

> AI Analytics. FDA recall Z-1107-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1107-2022. Source: US FDA. Licensed CC0.

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