Z-0482-2024Class II

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

Name: Z-0482-2024 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Creator: Heartware, Inc.
Published: 2023-10-31
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2023-10-31 / Open, Classified / root cause: labeling and UDI

FDA source

Heartware, Inc. began a recall of HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 on 2023-10-31. FDA classified it as Class II and gives the reason as "Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0482-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-31
Posted: 2023-12-02
Recalling firm: HeartWare, Inc.
Product: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).
Quantity in commerce: 126 units
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0476-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0477-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0478-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0479-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0480-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0481-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0482-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0483-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)