Reported Oct 26, 2016 · Terminated
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in…
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 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
- Lot codes and dates
- All Heartware Controllers manufactured after September 2014
- US Model No
14001401XX1403US
- International Model No
14001401XX1407XX
- Amount recalled
- 4235 Worldwide, 7272 units in U.S.
Where it was sold
Why it was recalled
Stop using this product now
Loose connector ports in controller body.
Using this product could cause serious injury, illness or death — stop using it now.
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