enforcement Primary ID: Z-0480-2024

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN (UDI Z-0480-2024)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA 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.

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ID: Z-2755-2026 View Full Alert →

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Technical Specifications

Model Number: N/A
Product Code / EMDN: Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
Device Name: 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Database Sync Date: 2026-08-09 10:06:36

Full Regulatory Attributes

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{
    "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 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN?

The registered manufacturer of record for 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN is Heartware, Inc..

What is the Primary UDI-DI identifier for 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0480-2024.

What classification code is assigned to this device?

This device is registered under product classification code Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA.

Other Devices by Heartware, Inc.

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