Reported Dec 13, 2023 · Ongoing
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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?
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- Lot codes and dates
- GTIN none
- Serial Numbers
HW25172HW25169FSCAHW25170FSCAHW25174FSCAGTIN 00763000170967
- Serial numbers
122 of 122 codes
HW42722HW42771HW42285HW41696HW41675HW40953HW41848HW41847HW41316HW41828HW41824HW41803HW41670HW41271HW41701HW41674HW41791HW41792HW41804HW41252HW41256HW41700HW41699HW41783HW41317HW41309HW41673HW41254HW40651HW40665HW40663HW41672HW41308HW41269HW41544HW41270HW41214HW41314HW40417HW41263HW41264HW41265HW41047HW41260HW41266HW41251HW41259HW41258HW40579HW41048HW41262HW41045HW40961HW40958HW40956HW41050HW41255HW40881HW40789HW40957
- 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.
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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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