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

    • BAT941874
    • BAT941880
    • BAT941886
    • BAT941935
    • BAT941937
    • BAT941944
    • BAT941948
    • BAT941960
    • BAT942348
    • BAT941747
    • BAT941897
    • BAT941955
    • BAT941959
    • BAT937852
    • BAT937853
    • BAT937887
    • BAT937889
    • BAT937893
    • BAT941119
    • BAT941132
    • BAT941148
    • BAT941962
    • BAT941976
    • BAT941988
    • BAT942254
    • BAT937888
    • BAT937890
    • BAT941133
    • BAT941145
    • BAT941147
    • BAT941149
    • BAT941303
    • BAT941963
    • BAT941965
    • BAT940874
    • BAT941024
    • BAT942202
    • BAT942217
    • BAT942241
    • BAT942270
    • BAT942272
    • BAT942199
    • BAT942203
    • BAT942212
    • BAT942214
    • BAT942218
    • BAT942222
    • BAT942224
    • BAT942242
    • BAT942248
    • BAT942267
    • BAT942271
    • BAT942273
    • BAT942311
    • BAT942329
    • BAT939092
    • BAT939174
    • BAT939176
    • BAT939178
    • BAT941257
  • serial numbers as of 08/23/2023

    689 of 689 codes

    • BAT944553
    • BAT944583
    • BAT944585
    • BAT944586
    • BAT944588
    • BAT944589
    • BAT937852
    • BAT937853
    • BAT945140
    • BAT946030
    • BAT942004
    • BAT942008
    • BAT942027
    • BAT942035
    • BAT942193
    • BAT942253
    • BAT946335
    • BAT946336
    • BAT946337
    • BAT946341
    • BAT946348
    • BAT946393
    • BAT946394
    • BAT946397
    • BAT946399
    • BAT946404
    • BAT946407
    • BAT946408
    • BAT945833
    • BAT945835
    • BAT945837
    • BAT945874
    • BAT946191
    • BAT946203
    • BAT946131
    • BAT942009
    • BAT942010
    • BAT942016
    • BAT942017
    • BAT942024
    • BAT942038
    • BAT945271
    • BAT945285
    • BAT946446
    • BAT946448
    • BAT942352
    • BAT942355
    • BAT942356
    • BAT942360
    • BAT942372
    • BAT942373
    • BAT945256
    • BAT945274
    • BAT945454
    • BAT946603
    • BAT946618
    • BAT946626
    • BAT946632
    • BAT945290
    • BAT945369
  • Serial Numbers

    754 of 754 codes

    • BAT653476
    • BAT653482
    • BAT653471
    • BAT653477
    • BAT653572
    • BAT650373
    • BAT650383
    • BAT650572
    • BAT650827
    • BAT650855
    • BAT650867
    • BAT651035
    • BAT651037
    • BAT651093
    • BAT651235
    • BAT651244
    • BAT651246
    • BAT651405
    • BAT651491
    • BAT651493
    • BAT653496
    • BAT653626
    • BAT650374
    • BAT650382
    • BAT650571
    • BAT650573
    • BAT650824
    • BAT650826
    • BAT650828
    • BAT650854
    • BAT651034
    • BAT651036
    • BAT651239
    • BAT651241
    • BAT651245
    • BAT651247
    • BAT651406
    • BAT651408
    • BAT651410
    • BAT651488
    • BAT651492
    • BAT652282
    • BAT653495
    • BAT653499
    • BAT653501
    • BAT650020
    • BAT650022
    • BAT650026
    • BAT650062
    • BAT650218
    • BAT650578
    • BAT650696
    • BAT651227
    • BAT653175
    • BAT653315
    • BAT650021
    • BAT650701
    • BAT653172
    • BAT653174
    • BAT653428
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Heartware, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.