FDA Device recall Z-1512-2022

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

FDA Device
Class I
ongoing
Published 2022-08-24

On 2022-08-24 the FDA classified a Class I recall of HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE by Heartware, citing 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 a….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1512-2022
Classification	Class I
Status	ongoing
Initiated	2022-06-28
Published	2022-08-24
Last updated	2026-09-13 11:56 UTC
Company	Heartware
Distribution	US

Product

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

Reason

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.

Identifiers

code_info	a. GTIN 00763000187767, Serial Numbers: BAT941874, BAT941880, BAT941886, BAT941935, BAT941937, BAT941944, BAT941948, B… a. GTIN 00763000187767, Serial Numbers: 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, BAT941259, BAT941263, BAT939173, BAT939175, BAT939177, BAT940999, BAT941262, BAT942204, BAT942206, BAT942236, BAT942240, BAT939078, BAT939086, BAT939088, BAT942256, BAT942262, BAT942264, BAT942266, BAT939075, BAT939079, BAT939085, BAT942261, BAT942265, BAT817284, BAT817286, BAT817290, BAT817295, BA

code_info

a. GTIN 00763000187767, Serial Numbers: BAT941874, BAT941880, BAT941886, BAT941935, BAT941937, BAT941944, BAT941948, B…

a. GTIN 00763000187767, Serial Numbers: 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, BAT941259, BAT941263, BAT939173, BAT939175, BAT939177, BAT940999, BAT941262, BAT942204, BAT942206, BAT942236, BAT942240, BAT939078, BAT939086, BAT939088, BAT942256, BAT942262, BAT942264, BAT942266, BAT939075, BAT939079, BAT939085, BAT942261, BAT942265, BAT817284, BAT817286, BAT817290, BAT817295, BA

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2022%22

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