Reported Dec 13, 2023 · Ongoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
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, Model Number 1100
- Lot codes and dates
- Serial numbers
HW001HW012HW016HW017HW023HW025HW028HW044HW045HW046HW047HW049HW050HW051HW061HW064HW083HW084HW086HW091HW094HW104HW105HW108HW109HW110HW114HW115HW116HW119HW126HW127HW129HW130HW131HW138HW139HW143HW146HW147HW153HW156HW161HW170HW181
- Serial numbers
- Amount recalled
- 45 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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