Heartware recalls
Heartware appears in 75 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 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 - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
FDA Device · Class II · 2023-12-13 · Heartware - STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
FDA Device · Class II · 2023-12-13 · Heartware - PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
FDA Device · Class II · 2023-12-13 · Heartware - HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech,…
FDA Device · Class II · 2023-06-28 · Heartware - HeartWare Model 1100
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF MCS1705PU
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF 1104JP
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF 1104CA-CLIN
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare Model 1101
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF 1104
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF 1205
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare Model 1102
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare HVAD Pump Kit, REF 1103
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Device · Class I · 2022-08-24 · Heartware - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System E…
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System
FDA Device · Class II · 2022-03-16 · Heartware - Medtronic HVAD Pump Implant Kits
FDA Device · Class II · 2021-09-22 · Heartware - HeartWare HVAD Driveline Extension Cable, REF 100
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Pump Implant Kit, REF 1125
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Pump Implant Kit, REF 1153
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Implant Kit, REF 1104JP
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Pump Implant Kit, REF 1103
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Pump Implant Kit, REF 1104
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Device · Class I · 2021-08-18 · Heartware - HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory le…
FDA Device · Class II · 2021-07-21 · Heartware - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class I · 2021-04-28 · Heartware - Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 143…
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 140…
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511I…
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Mo…
FDA Device · Class I · 2021-02-10 · Heartware - Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Device · Class I · 2020-06-03 · Heartware