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Mechanical Circulatory Support Adverse Event Data

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

Total Reports

196,058

Devices Tracked

200

Reports (30d)

2,310

Active Signals

93

Monthly Report Volume
Event Type Breakdown

Devices in MCS

DeviceTotal ReportsLast 30d
HVAD PUMP IMPLANT KITDSQ
33,4900
HeartMate 3™DSQ
17,643251
HeartMate™DSQ
16,874135
ImpellaOZD
14,846680
CARDIOSAVE HYBRID, TYPE B PLUGDSP
13,675167
ImpellaOZD
11,1501
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ
7,25419
ImpellaOZD
7,25498
HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERYDSQ
5,7240
ImpellaOZD
5,697135
HeartMate 3™DSQ
5,62397
HEARTWARE CONTROLLERDSQ
4,8100
CS300 Intra-Aortic Balloon Pump, English, 110VDSP
4,71716
HVAD Pump Implant KitDSQ
3,04514
HEARTWARE VENTRICULAR ASSIST DRIVELINEDSQ
2,8910
CARDIOSAVE HYBRID W/ E/F PLUGDSP
2,06336
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)DSP
1,9186
ImpellaOZD
1,75637
CARDIOSAVE HYBRID, TYPE I PLUGDSP
1,47535
CARDIOSAVE HYBRID, TYPE G PLUGDSP
1,43321
THORATEC® HEARTMATE II®, SYSTEM CONTROLLERDSQ
1,3449
ImpellaOZD
1,3430
CS300 Intra-Aortic Balloon Pump, English, 220VDSP
1,21714
CS100 Intra-Aortic Balloon Pump, English, 220VDSP
1,2078
HeartWare® ControllerDSQ
1,1641

1–25 of 200 devices

1 / 8

All MCS device pages (62)

ImpellaHVAD PUMP IMPLANT KITHeartMate 3HeartMateCARDIOSAVE HYBRID, TYPE B PLUGTHORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERYARROW IABPHEARTWARE CONTROLLERCS300 Intra-Aortic Balloon Pump, English, 110VHVAD Pump Implant KitHEARTWARE VENTRICULAR ASSIST DRIVELINECARDIOSAVE HYBRID W/ E/F PLUGSENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)CARDIOSAVE HYBRID, TYPE I PLUGCARDIOSAVE HYBRID, TYPE G PLUGTHORATEC HEARTMATE II, SYSTEM CONTROLLERCS300 Intra-Aortic Balloon Pump, English, 220VCS100 Intra-Aortic Balloon Pump, English, 220VHeartWare ControllerTHORATEC HEARTMATE II, LVAS IMPLANT KIT (WITH SEALED GRAFTS)CS100 Intra-Aortic Balloon Pump, Chinese, 220VCARDIOSAVE HYBRID, 3.1 EDITIONTHORATEC HEARTMATE II, LVAS IMPLANT KITEXCORTRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESHEARTWARE SHOULDER PACKTRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESHEARTWARE WAIST PACKSENSATION PLUS 7.5Fr. 40cc IAB & AccessoriesSensation Plus 8Fr. 50cc IAB with Accessories, US OnlyTHORATEC HEARTMATE, SYSTEM MONITORCS100 Intra-Aortic Balloon Pump, English, 110VSensation 7Fr. 40cc IABHeartWare Waist PackCS300 Intra-Aortic Balloon Pump, Japanese, 110VLinear 7.5Fr. 40cc IABHVAD ControllerPUMP 381 PUMP SET (US)CS300 Intra-Aortic Balloon Pump, Chinese, 220VCARDIOSAVE HYBRID TYPE D PLUGCS300 Intra-Aortic Balloon Pump, Italian, 220VHeartWare BatteryCARDIOSAVE HYBRID TYPE I (AU)CARDIOSAVE RESCUEHEARTMATE 3HEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINESensation 7Fr. 34cc IABMEGA 8Fr. 50cc IAB (with Statlock)THORATEC HEARTMATE II, LVAS IMPLANT KIT, US, EPSensation Plus 7.5Fr. 40cc IAB with Accessories, US OnlyLinear 7.5Fr. 34cc IABCS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOMPATIENT PACKCS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTLTHORATEC HEARTMATE II, SYSTEM CONTROLLER, US, EPMEGA 8Fr. 50cc IABBALLOON CATHETERPURGE CASSETTE GEN 2, STERILE, NON QSKHeartMate GoGearHeartMate TouchYAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Post-market surveillance: a practical guide

Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.

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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.