Mechanical Circulatory Support Adverse Event Data

IABP, Impella, LVAD (HeartMate), and ventricular bypass device adverse event data.

Total Reports

180,492

Devices Tracked

200

Reports (30d)

3,845

Active Signals

211

Monthly Report Volume

Event Type Breakdown

Devices in MCS

Device	Manufacturer	Type	Total Reports	Last 30d
HVAD Pump Implant KitDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	36,699	44
HeartMate 3™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	16,020	185
HeartMate™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	15,861	51
CARDIOSAVE HYBRID, TYPE B PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	12,585	245
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	11,010	195
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	10,300	46
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	7,119	20
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	5,788	548
HeartMate 3™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	4,940	110
CS300 Intra-Aortic Balloon Pump, English, 110VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	4,548	33
HVAD® ControllerDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	3,862	20
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	3,840	770
HeartWare® BatteryDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	2,573	2
HeartWare® ControllerDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	2,357	9
HEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINEDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	2,331	13
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	2,158	101
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)DSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	2,097	59
CARDIOSAVE HYBRID W/ E/F PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,878	42
HeartWare® BatteryDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	1,397	2
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	1,341	0
THORATEC® HEARTMATE II®, SYSTEM CONTROLLERDSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	1,301	8
CARDIOSAVE HYBRID, TYPE G PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,271	42
CARDIOSAVE HYBRID, TYPE I PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,240	66
CS100 Intra-Aortic Balloon Pump, English, 220VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,133	17
CS300 Intra-Aortic Balloon Pump, English, 220VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,112	11

1–25 of 200 devices

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.