# FDA recall Z-1110-2022

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

## Product

Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System.  IFUs are distributed as part of the Pump Implant Kits models:  1103, MCS1705PU, 1104, and 1104JP.  Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers:  IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

## Reason for recall

Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.

## Distribution

Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom

## Key facts

- **Recall number:** Z-1110-2022
- **Recalling firm:** Medtronic 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:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1110-2022

## Citation

> AI Analytics. FDA recall Z-1110-2022. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1110-2022. Source: US FDA. Licensed CC0.

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