GUDIDData
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enforcement Primary ID: Z-0483-2024

PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU (UDI Z-0483-2024)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU - Primary ID Z-0483-2024

Device Regulatory Overview

The PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification GTIN 00888707005364, Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765; GTIN 00888707005715, Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers: HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696; GTIN 00888707007160, Serial Numbers: HW43453; GTIN 00888707009041, Serial Numbers: HW43032, HW42484, HW42522, HW43489; GTIN 00888707009423, Serial Numbers: HW43068; GTIN 00888707009454, Serial Numbers: HW43096; GTIN 00888707009485, Serial Numbers: HW42688; GTIN 00888707009492, Serial Numbers: HW42926 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
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
Product Code / EMDN
GTIN 00888707005364, Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765; GTIN 00888707005715, Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers: HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696; GTIN 00888707007160, Serial Numbers: HW43453; GTIN 00888707009041, Serial Numbers: HW43032, HW42484, HW42522, HW43489; GTIN 00888707009423, Serial Numbers: HW43068; GTIN 00888707009454, Serial Numbers: HW43096; GTIN 00888707009485, Serial Numbers: HW42688; GTIN 00888707009492, Serial Numbers: HW42926
Device Name
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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 PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU?

The registered manufacturer of record for PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU is Heartware, Inc..

What is the Primary UDI-DI identifier for PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0483-2024.

What classification code is assigned to this device?

This device is registered under product classification code GTIN 00888707005364, Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765; GTIN 00888707005715, Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers: HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696; GTIN 00888707007160, Serial Numbers: HW43453; GTIN 00888707009041, Serial Numbers: HW43032, HW42484, HW42522, HW43489; GTIN 00888707009423, Serial Numbers: HW43068; GTIN 00888707009454, Serial Numbers: HW43096; GTIN 00888707009485, Serial Numbers: HW42688; GTIN 00888707009492, Serial Numbers: HW42926.

Other Devices by Heartware, Inc.

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