Reported Aug 7, 2013 · Terminated
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
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 HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Lot codes and dates
- US product
Model 14001401US1403US1404
- International
Model 14001401XX1407XX1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
- US product
- Amount recalled
- 76 (US) and 82 (International)
Where it was sold
Why it was recalled
Potential to electrostatic discharged (ESD)
This product could cause temporary or reversible health problems — stop using it.
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