FDA Device recall Z-0478-2024

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

FDA Device
Class II
ongoing
Published 2023-12-13

On 2023-12-13 the FDA classified a Class II recall of PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 by Heartware, citing updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0478-2024
Classification	Class II
Status	ongoing
Initiated	2023-10-31
Published	2023-12-13
Last updated	2026-09-13 11:56 UTC
Company	Heartware
Distribution	n/a

Product

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

Reason

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Identifiers

code_info	GTIN none, Serial Numbers: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, H… GTIN none, Serial Numbers: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046, HW11047, HW11050, HW11051, HW11052, HW11053, HW11054, HW11057, HW11060, HW11061, HW11062, HW11063, HW11064, HW11065, HW11067, HW11070, HW11071, HW11072, HW11074, HW11075, HW11076, HW11077, HW11078, HW11082, HW11083, HW11085, HW11086, HW11087, HW11088, HW11089, HW11091, HW11092, HW11093, HW11094, HW11096, HW11100, HW11101, HW11103, HW11105, HW11106, HW11107, HW11109, HW11111, HW11112, HW11113, HW11114, HW11116, HW11117, HW11118, HW11119, HW11120, HW11121, HW11122, HW11123, HW11125, HW11126, HW11129, HW11130, HW11133, HW11134, HW11137, HW11138, HW11139, HW11140, HW11141, HW11142, HW11146, HW11147, HW11148, HW11149, HW11150, HW11151, HW11152, HW11153, HW11155, HW11157, HW11160, HW11161, HW11164, HW11165, HW11166, HW11168, HW11171, HW11172, HW11173,

code_info

GTIN none, Serial Numbers: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, H…

GTIN none, Serial Numbers: HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046, HW11047, HW11050, HW11051, HW11052, HW11053, HW11054, HW11057, HW11060, HW11061, HW11062, HW11063, HW11064, HW11065, HW11067, HW11070, HW11071, HW11072, HW11074, HW11075, HW11076, HW11077, HW11078, HW11082, HW11083, HW11085, HW11086, HW11087, HW11088, HW11089, HW11091, HW11092, HW11093, HW11094, HW11096, HW11100, HW11101, HW11103, HW11105, HW11106, HW11107, HW11109, HW11111, HW11112, HW11113, HW11114, HW11116, HW11117, HW11118, HW11119, HW11120, HW11121, HW11122, HW11123, HW11125, HW11126, HW11129, HW11130, HW11133, HW11134, HW11137, HW11138, HW11139, HW11140, HW11141, HW11142, HW11146, HW11147, HW11148, HW11149, HW11150, HW11151, HW11152, HW11153, HW11155, HW11157, HW11160, HW11161, HW11164, HW11165, HW11166, HW11168, HW11171, HW11172, HW11173,

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-0478-2024%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.