Mechanical Circulatory Support Adverse Event Data

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

Total Reports

179,686

Devices Tracked

200

Reports (30d)

2,955

Active Signals

183

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)	36,994	58
HeartMate 3™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	16,279	259
HeartMate™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	16,109	161
CARDIOSAVE HYBRID, TYPE B PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	12,800	214
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	11,084	74
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	10,600	163
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	7,148	29
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	6,346	558
HeartMate 3™DSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	5,061	121
CS300 Intra-Aortic Balloon Pump, English, 110VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	4,588	40
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	4,367	525
HVAD® ControllerDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	3,882	20
HeartWare® BatteryDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	2,576	3
HeartWare® ControllerDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	2,293	1
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	2,240	82
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)DSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	2,133	36
CARDIOSAVE HYBRID W/ E/F PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,901	23
HeartWare® BatteryDSQ	MEDTRONIC, INC.	Ventricular Assist Device (LVAD)	1,397	0
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	1,342	1
THORATEC® HEARTMATE II®, SYSTEM CONTROLLERDSQ	Thoratec Corporation	Ventricular Assist Device (LVAD)	1,310	9
CARDIOSAVE HYBRID, TYPE G PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,309	38
CARDIOSAVE HYBRID, TYPE I PLUGDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,276	36
CS100 Intra-Aortic Balloon Pump, English, 220VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,149	16
CS300 Intra-Aortic Balloon Pump, English, 220VDSP	Datascope Corp.	Intra-Aortic Balloon Pump System (IABP)	1,132	20
ImpellaOZD	Abiomed, Inc.	Temporary Left Heart Support Pump (Impella)	1,077	65

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.