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Mechanical Circulatory Support Adverse Event Data

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

Total Reports

193,693

Devices Tracked

200

Reports (30d)

2,464

Active Signals

22

Monthly Report Volume
Event Type Breakdown

Devices in MCS

DeviceTotal ReportsLast 30d
HVAD Pump Implant KitDSQ
37,38419
HeartMate 3™DSQ
17,392264
HeartMate™DSQ
16,61635
ImpellaOZD
14,012143
CARDIOSAVE HYBRID, TYPE B PLUGDSP
13,507176
ImpellaOZD
11,14610
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ
7,23519
ImpellaOZD
7,156159
ImpellaOZD
5,562220
HeartMate 3™DSQ
5,52690
CS300 Intra-Aortic Balloon Pump, English, 110VDSP
4,70123
HVAD® ControllerDSQ
3,94312
HeartWare® BatteryDSQ
2,5834
HEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINEDSQ
2,35912
HeartWare® ControllerDSQ
2,3101
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)DSP
2,24312
CARDIOSAVE HYBRID W/ E/F PLUGDSP
2,02734
ImpellaOZD
1,719160
CARDIOSAVE HYBRID, TYPE I PLUGDSP
1,44031
CARDIOSAVE HYBRID, TYPE G PLUGDSP
1,41226
ImpellaOZD
1,3430
THORATEC® HEARTMATE II®, SYSTEM CONTROLLERDSQ
1,3352
HeartWare® BatteryDSQ
1,2770
CS300 Intra-Aortic Balloon Pump, English, 220VDSP
1,20328
CS100 Intra-Aortic Balloon Pump, English, 220VDSP
1,19916

1–25 of 200 devices

1 / 8

All MCS device pages (60)

ImpellaHVAD Pump Implant KitHeartMate 3HeartMateCARDIOSAVE HYBRID, TYPE B PLUGTHORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)ARROW IABPCS300 Intra-Aortic Balloon Pump, English, 110VHVAD ControllerHeartWare BatteryHEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINEHeartWare ControllerSENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)CARDIOSAVE HYBRID W/ E/F PLUGCARDIOSAVE HYBRID, TYPE I PLUGCARDIOSAVE HYBRID, TYPE G PLUGTHORATEC HEARTMATE II, SYSTEM CONTROLLERCS300 Intra-Aortic Balloon Pump, English, 220VCS100 Intra-Aortic Balloon Pump, English, 220VHEARTWARETHORATEC HEARTMATE II, LVAS IMPLANT KIT (WITH SEALED GRAFTS)CS100 Intra-Aortic Balloon Pump, Chinese, 220VCARDIOSAVE HYBRID, 3.1 EDITIONTHORATEC HEARTMATE II, LVAS IMPLANT KITTRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESHeartWare Shoulder PackTRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESSENSATION PLUS 7.5Fr. 40cc IAB & AccessoriesHeartWare Waist PackCS100 Intra-Aortic Balloon Pump, English, 110VCS300 Intra-Aortic Balloon Pump, Japanese, 110VLinear 7.5Fr. 40cc IABPUMP 381 PUMP SET (US)Sensation 7Fr. 40cc IABCS300 Intra-Aortic Balloon Pump, Chinese, 220VCARDIOSAVE HYBRID TYPE D PLUGCARDIOSAVE HYBRID TYPE I (AU)THORATEC HEARTMATE, SYSTEM MONITORCARDIOSAVE RESCUECS300 Intra-Aortic Balloon Pump, Italian, 220VHEARTMATE 3EXCORSensation 7Fr. 34cc IABMEGA 8Fr. 50cc IAB (with Statlock)HVAD PUMP IMPLANT KITTHORATEC HEARTMATE II, LVAS IMPLANT KIT, US, EPPatient PackLinear 7.5Fr. 34cc IABCS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOMSensation Plus 7.5Fr. 40cc IAB with Accessories, US OnlyTHORATEC HEARTMATE II, SYSTEM CONTROLLER, US, EPCS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTLMEGA 8Fr. 50cc IABHVAD Pump Outflow GraftPURGE CASSETTE GEN 2, STERILE, NON QSKBALLOON CATHETERHVAD PUMP IMPLANT KITSensation Plus 8Fr. 50cc IAB with Accessories, US OnlyYAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)HeartMate GoGear

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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.