GUDIDData
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enforcement Primary ID: Z-2478-2021

Medtronic HVAD Pump Implant Kits (UDI Z-2478-2021)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Medtronic HVAD Pump Implant Kits - Primary ID Z-2478-2021

Device Regulatory Overview

The Medtronic HVAD Pump Implant Kits (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers 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 →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 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
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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
Medtronic HVAD Pump Implant Kits
Database Sync Date
2026-08-09 10:06:52

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 Medtronic HVAD Pump Implant Kits?

The registered manufacturer of record for Medtronic HVAD Pump Implant Kits is Heartware, Inc..

What is the Primary UDI-DI identifier for Medtronic HVAD Pump Implant Kits?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2478-2021.

What classification code is assigned to this device?

This device is registered under product classification code Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers.

Other Devices by Heartware, Inc.

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