enforcement Primary ID: Z-0482-2024

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 (UDI Z-0482-2024)

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/IMPLANT KIT OUS, Model Number 1205 (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Serial numbers: HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028 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...

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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...

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Technical Specifications

Model Number: N/A
Product Code / EMDN: Serial numbers: HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028
Device Name: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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/IMPLANT KIT OUS, Model Number 1205?

The registered manufacturer of record for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 is Heartware, Inc..

What is the Primary UDI-DI identifier for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0482-2024.

What classification code is assigned to this device?

This device is registered under product classification code Serial numbers: HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028.

Other Devices by Heartware, Inc.

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