Reported Oct 19, 2016 · Ongoing
HeartWare Ventricular Assist System (HVAD), US product
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 (HVAD), US product
3 of 3 products
| Model / number | Product as published |
|---|---|
1103 | and International Product |
1104XX. | Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from |
| — | refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. |
- Lot codes and dates
- All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
- Amount recalled
- 344 pumps
Where it was sold
Why it was recalled
Stop using this product now
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Using this product could cause serious injury, illness or death — stop using it now.
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