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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Heartware
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Device · Class II · 2023-12-13 · Heartware - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Device · Class II · 2023-12-13 · Heartware - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Device · Class II · 2023-12-13 · Heartware
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.