Reported Dec 13, 2023 · Ongoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
- Lot codes and dates
- Serial numbers
126 of 126 codes
HW1412HW1413HW1416HW1433HW1435HW1490HW1493HW1495HW1496HW1593HW1599HW1641HW1661HW1662HW1663HW1664HW1695HW1696HW1698HW1699HW1706HW1708HW1709HW1718HW1727HW1730HW1740HW1741HW1747HW1754HW1760HW1764HW1765HW1768HW1773HW1774HW1777HW1778HW1783HW1785HW1796HW1804HW1808HW1810HW1811HW1815HW1819HW1821HW1822HW1823HW1824HW1825HW1826HW1828HW1830HW1831HW1832HW1839HW1841HW1856
- Serial numbers
- Amount recalled
- 126 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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