enforcement Primary ID: Z-0475-2024

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 (UDI Z-0475-2024)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification 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 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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Technical Specifications

Model Number: N/A
Product Code / EMDN: 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
Device Name: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Database Sync Date: 2026-08-09 10:06:36

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100?

The registered manufacturer of record for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 is Heartware, Inc..

What is the Primary UDI-DI identifier for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0475-2024.

What classification code is assigned to this device?

This device is registered under product classification code 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.

Other Devices by Heartware, Inc.

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