Reported Mar 4, 2015 · Terminated
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac…
HeartWare Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 System (HeartWare
- Controller) Product UsageFor use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
- Lot codes and dates
- Product Codes- US product
Model No.: 14001401US
- International productModel No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
- Product Codes- US product
- Amount recalled
- 4,845
Where it was sold
Why it was recalled
Stop using this product now
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Using this product could cause serious injury, illness or death — stop using it now.
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