Reported Aug 24, 2022 · Ongoing
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
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 Device (HVAD) System Batteries, Product Number 1650DE
- Lot codes and dates
- a. GTIN 00763000187767
- Serial Numbers
1,511 of 1,511 codes
BAT941874BAT941880BAT941886BAT941935BAT941937BAT941944BAT941948BAT941960BAT942348BAT941747BAT941897BAT941955BAT941959BAT937852BAT937853BAT937887BAT937889BAT937893BAT941119BAT941132BAT941148BAT941962BAT941976BAT941988BAT942254BAT937888BAT937890BAT941133BAT941145BAT941147BAT941149BAT941303BAT941963BAT941965BAT940874BAT941024BAT942202BAT942217BAT942241BAT942270BAT942272BAT942199BAT942203BAT942212BAT942214BAT942218BAT942222BAT942224BAT942242BAT942248BAT942267BAT942271BAT942273BAT942311BAT942329BAT939092BAT939174BAT939176BAT939178BAT941257
- serial numbers as of 08/23/2023
689 of 689 codes
BAT944553BAT944583BAT944585BAT944586BAT944588BAT944589BAT937852BAT937853BAT945140BAT946030BAT942004BAT942008BAT942027BAT942035BAT942193BAT942253BAT946335BAT946336BAT946337BAT946341BAT946348BAT946393BAT946394BAT946397BAT946399BAT946404BAT946407BAT946408BAT945833BAT945835BAT945837BAT945874BAT946191BAT946203BAT946131BAT942009BAT942010BAT942016BAT942017BAT942024BAT942038BAT945271BAT945285BAT946446BAT946448BAT942352BAT942355BAT942356BAT942360BAT942372BAT942373BAT945256BAT945274BAT945454BAT946603BAT946618BAT946626BAT946632BAT945290BAT945369
- Serial Numbers
754 of 754 codes
BAT653476BAT653482BAT653471BAT653477BAT653572BAT650373BAT650383BAT650572BAT650827BAT650855BAT650867BAT651035BAT651037BAT651093BAT651235BAT651244BAT651246BAT651405BAT651491BAT651493BAT653496BAT653626BAT650374BAT650382BAT650571BAT650573BAT650824BAT650826BAT650828BAT650854BAT651034BAT651036BAT651239BAT651241BAT651245BAT651247BAT651406BAT651408BAT651410BAT651488BAT651492BAT652282BAT653495BAT653499BAT653501BAT650020BAT650022BAT650026BAT650062BAT650218BAT650578BAT650696BAT651227BAT653175BAT653315BAT650021BAT650701BAT653172BAT653174BAT653428
- Amount recalled
- 19616 batteries
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Using this product could cause serious injury, illness or death — stop using it now.
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