Heartware recalls

Heartware has 69 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 13 Dec 2023. 60 are still ongoing. The most frequent reason is device malfunction.

Total recalls69since 2013

Last 12 months0reported

Class I3551% of total

Ongoing60latest 13 Dec 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 35 51%Class II 34 49%Class III 0 0%

Why heartware is recalled

Product types

Other Medical Devices6290%
Patient Monitors710%

By year

2023812%
20221522%
20212130%
202069%
201834%
201723%
201634%
2015710%
201423%
201323%

Ongoing heartware recalls

60 active

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Sterile Hvad (HeartWare Ventricular Assist Device) Pump (US) recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Pump 1104 Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL

All heartware recalls, newest first

69 total

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Sterile Hvad (HeartWare Ventricular Assist Device) Pump (US) recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Pump 1104 Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant recalled	Heartware	Sterility	FL
28 Jun 2023Device	CLASS II	Ventricular Assist Device System recalled by Heartware	Heartware	Other	Nationwide
28 Dec 2022Device	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL
28 Dec 2022Device	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.