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enforcement Primary ID: Z-0747-2023

HeartWare HVAD Pump Kit, REF 1104CA-CLIN (UDI Z-0747-2023)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HeartWare HVAD Pump Kit, REF 1104CA-CLIN - Primary ID Z-0747-2023

Device Regulatory Overview

The HeartWare HVAD Pump Kit, REF 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, HW24755, HW24763 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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🔒 Compromised Lot & Serial Numbers Locked
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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...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2793-2026 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Device Name
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
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 HeartWare HVAD Pump Kit, REF 1104CA-CLIN?

The registered manufacturer of record for HeartWare HVAD Pump Kit, REF 1104CA-CLIN is Heartware, Inc..

What is the Primary UDI-DI identifier for HeartWare HVAD Pump Kit, REF 1104CA-CLIN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0747-2023.

What classification code is assigned to this device?

This device is registered under product classification code Serial Numbers: HW24101, HW24102, HW24103, HW24104, HW24755, HW24763.

Other Devices by Heartware, Inc.

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