Reported Mar 16, 2022 · Ongoing
HeartWare Ventricular Assist Device (HVAD) System
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?
- HeartWare Ventricular Assist Device (HVAD) System
- Lot codes and dates
- All lots/serials
- for the following product model numbers
1440140014011401AU1401BR1401CA1401CH1401DE1401GB1401IL1401IN1401IT1401JP1401US1403US1407AR1407AU1407BR1407CA1407CA-CLIN1407CH1407DE1407GB1407IL1407IN1407IT1407JP1407KR1425AU1425CA1425DE1425GB1425IL1425IT1425US1430AR1430AU1430CA1430CH1430DE1430GB1430IL1430IN1430IT1430JP1430US1440165016501650CA-CLIN1650DE
- Amount recalled
- 197,889 units
Why it was recalled
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
This product could cause temporary or reversible health problems — stop using it.
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