Reported Jul 20, 2016 · Terminated
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650,…
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 BatteryLithium Ion14.8 VRx only. Catalog 1650 (US) and 16501650-DE
- and A00035 (OUS) Product UsageUsed as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter
- Lot codes and dates
- Serial numbers ranging BAT000001 to BAT199999.
- Amount recalled
- 18, 631
Where it was sold
Why it was recalled
Stop using this product now
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Using this product could cause serious injury, illness or death — stop using it now.
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