FDA.reportPublic FDA data

Implantable ventricular circulatory assist system

Definition
A portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.
GUDID devices
108
Last updated
2026-10-06 03:50:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000923594HeartWare™ MonitorMEDTRONIC, INC.1521MCS2026-09-25
00763000923709Power CordMEDTRONIC, INC.MCS1621PC2026-09-25
00763000923792Monitor Power CordMEDTRONIC, INC.MCS1622PC2026-09-25
00763000923655HeartWare™ BatteryHeartware Inc.16502026-05-01
00763000923679HeartWare™ Waist PackHeartware Inc.20502026-05-31
00763000923686HeartWare™ Shoulder PackHeartware Inc.20602026-05-31
00888707005388HVAD® Pump Surgical ToolsHeartware Inc.MCS1718ST2020-12-14
00888707008204HVAD® Pump Surgical ToolsHeartware Inc.13182020-11-10
00888707008723HVAD® Pump Surgical Tools – Extended LengthHeartware Inc.13282020-11-10
00817278012211Surge CardiovascularMed Michigan Holdings, LLCLVV-016S2017-10-27
00817278012228Surge CardiovascularMed Michigan Holdings, LLCLVV-018S2017-10-27
00817278012235Surge CardiovascularMed Michigan Holdings, LLCLVV-020S2017-10-27
05415067038821HeartMate 3™Thoratec Corporation10012390GBL2025-05-16
05415067039323HeartMate 3™Thoratec Corporation106524US2025-04-02
00763000989514HVAD™ ControllerHeartware Inc.MCS1421CN2025-08-30
05415067038784HeartMate 3™Thoratec Corporation100058772025-07-21
00763000629717HeartWare® BatteryHeartware Inc.1650DE2023-05-19
00888707007641HVAD® Pump Outflow GraftHeartware Inc.11252020-11-10
00888707007658HVAD® ControllerHeartware Inc.14202020-11-10
00888707008020Alarm AdapterHeartware Inc.14502020-11-10
00888707008037Patient PackHeartware Inc.14752020-11-10
00888707008044USB Flash DriveHeartware Inc.15602020-11-10
00888707008051Data CableHeartware Inc.15752020-11-10
00888707008778HeartWare® BatteryHeartware Inc.1650DE2020-11-10
00888707008785Explant KitHeartware Inc.17502020-11-10
00888707009218HeartWare® Controller AC AdapterHeartware Inc.1430US2022-08-15
00888707009256HeartWare® MonitorHeartware Inc.1521US2022-08-15
00888707009935HeartWare® Controller DC AdapterHeartware Inc.14402022-08-15
00888707009942HeartWare® BatteryHeartware Inc.1650DE2022-08-15
00888707010160Alarm Adapter Heartware Inc.14502022-08-15
00888707010177Data Cable Heartware Inc.15752022-08-15
05415067039286HeartMate 3™Thoratec Corporation106522US2022-06-14
00888707007313HeartWare® Monitor AC AdapterHeartware Inc.1555US2021-07-16
00888707009041HVAD® Pump Implant KitHeartware Inc.MCS1705PU2021-03-01
00888707005364HVAD® Pump Implant KitHeartware Inc.MCS1705PU2020-12-14
00888707005371HVAD® Pump Implant AccessoriesHeartware Inc.MCS1753AK2020-12-14
00888707005395HVAD® Pump Surgical Tools – Extended LengthHeartware Inc.MCS1728ST2020-12-14
00888707007634HVAD® Pump Outflow GraftHeartware Inc.MCS1725OG2020-12-14
00888707006880HeartWare® Controller DC AdapterHeartware Inc.14402020-06-29
00888707006897HeartWare® BatteryHeartware Inc.1650DE2020-06-29
00888707000260HeartWare® Controller DC AdapterHeartware Inc.14402017-05-18
00888707000307HeartWare® Controller AC AdapterHeartware Inc.1430US2017-05-18
00888707000369HeartWare® BatteryHeartware Inc.1650DE2017-05-18
00888707000420HVAD® ControllerHeartware Inc.14202017-05-18
00888707000451HVAD® Pump Surgical Tools - Extended LengthHeartware Inc.13282018-04-11
00888707000468Heartware® MonitorHeartware Inc.1521US2018-05-31
00888707000475HeartWare® ControllerHeartware Inc.1403US2017-05-18
00888707001632HeartWare® MonitorHeartware Inc.1520US2017-05-18
00888707002639HVAD® Pump Implant KitHeartware Inc.11032017-05-18
00888707002646HeartWare® BatteryHeartware Inc.1650DE2018-03-05
00888707002721HeartWare® Monitor AC AdapterHeartware Inc.1555US2017-10-27
00888707002738HeartWare® Controller AC AdapterHeartware Inc.1430US2017-10-27
00888707002745HeartWare® Controller DC AdapterHeartware Inc.14402017-10-27
00888707003261HVAD Pump Implant KitHeartware Inc.11032018-10-22
00888707005692HeartWare® BatteryHeartware Inc.1650DE2018-08-24
00888707005708HeartWare® BatteryHeartware Inc.1650DE2018-08-24
00888707006842HeartWare® Controller DC AdapterHeartware Inc.14402019-10-07
00888707006859HVAD® ControllerHeartware Inc.1403US2019-10-07
00888707006866HeartWare® Controller AC AdapterHeartware Inc.1430US2019-10-07
00888707006873HeartWare® BatteryHeartware Inc.1650DE2019-10-07
00813024013082Thoratec® HeartMate 3™Thoratec Corporation100058772018-10-19
05415067030801Thoratec® HeartMate 3™Thoratec Corporation106522US2019-05-23
05415067030269HeartMate 3™Thoratec Corporation10012390GBL2018-10-15
10817278012218Surge CardiovascularAlliant Enterprises, LLCLVV-016S2017-10-27
10817278012225Surge CardiovascularAlliant Enterprises, LLCLVV-018S2017-10-27
10817278012232Surge CardiovascularAlliant Enterprises, LLCLVV-020S2017-10-27
00813024010616THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EPThoratec Corporation1036952014-09-20
00813024011170THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)Thoratec Corporation1049112014-09-20
00813024011217THORATEC® HEARTMATE II®, PUMP AND CONTROLLER ONLY KITThoratec Corporation1059032014-09-20
00813024011224THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)Thoratec Corporation1060152014-09-20
00813024011644THORATEC® HEARMATE II®, LVAS IMPLANT KIT(WITH SEALED GRAFTS)Thoratec Corporation106015Y2014-09-20
00813024011651THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFT)Thoratec Corporation104911Y2014-09-20
00813024011996THORATEC® HEARTMATE II®, LVAS IMPLANT KITThoratec Corporation1078012014-09-20
00813024013198THORATEC® HeartMate 3™ LVAS Mini Kit Thoratec Corporation100016962017-08-30
00813024013297Thoratec® HeartMate 3™Thoratec Corporation106524US2017-08-30
00813502010251AB5000Abiomed, Inc.AB Vent Set, 32FR V/A & 10MM2014-07-31
00813502010268AB5000Abiomed, Inc.AB Vent Set. 42F V/A & 10mm2014-07-31
00813502010275AB5000Abiomed, Inc.AB Pump Set 10mm/32 Atrial (Hem)2014-07-31
00813502010282AB5000Abiomed, Inc.AB Pump Set 10mm/32x2 Atrial (Hem)2014-07-31
00813502010299AB5000Abiomed, Inc.AB Pump Set 10mm/32 Apical (Hem)2014-07-31