ClaripulseClaripulse™
Get Early Access

Mechanical Circulatory Support Adverse Event Data

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

Total Reports

184,357

Devices Tracked

200

Reports (30d)

2,071

Active Signals

176

Monthly Report Volume
Event Type Breakdown

Devices in MCS

DeviceTotal ReportsLast 30d
HVAD Pump Implant KitDSQ
37,30661
HeartMate 3™DSQ
16,779242
HeartMate™DSQ
16,395144
ImpellaOZD
13,239183
CARDIOSAVE HYBRID, TYPE B PLUGDSP
13,178149
ImpellaOZD
11,11415
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ
7,19523
ImpellaOZD
6,779198
HeartMate 3™DSQ
5,289113
ImpellaOZD
5,034309
CS300 Intra-Aortic Balloon Pump, English, 110VDSP
4,65830
HVAD® ControllerDSQ
3,91519
HeartWare® BatteryDSQ
2,5770
HeartWare® ControllerDSQ
2,3081
SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)DSP
2,21033
CARDIOSAVE HYBRID W/ E/F PLUGDSP
1,96929
CARDIOSAVE HYBRID, TYPE I PLUGDSP
1,38536
CARDIOSAVE HYBRID, TYPE G PLUGDSP
1,36331
ImpellaOZD
1,3420
THORATEC® HEARTMATE II®, SYSTEM CONTROLLERDSQ
1,3244
HeartWare® BatteryDSQ
1,2742
ImpellaOZD
1,23476
CS100 Intra-Aortic Balloon Pump, English, 220VDSP
1,17412
CS300 Intra-Aortic Balloon Pump, English, 220VDSP
1,16417
THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)DSQ
9671

1–25 of 200 devices

1 / 8

All MCS device pages (53)

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 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 CONTROLLERCS100 Intra-Aortic Balloon Pump, English, 220VCS300 Intra-Aortic Balloon Pump, English, 220VTHORATEC HEARTMATE II, LVAS IMPLANT KIT (WITH SEALED GRAFTS)HeartWare Waist PackCS100 Intra-Aortic Balloon Pump, Chinese, 220VCARDIOSAVE HYBRID, 3.1 EDITIONTHORATEC HEARTMATE II, LVAS IMPLANT KITHeartWare Shoulder PackTRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESTRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESSENSATION PLUS 7.5Fr. 40cc IAB & AccessoriesCS100 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 I (AU)CARDIOSAVE HYBRID TYPE D PLUGTHORATEC HEARTMATE, SYSTEM MONITORCARDIOSAVE RESCUECS300 Intra-Aortic Balloon Pump, Italian, 220VEXCORSensation 7Fr. 34cc IABTHORATEC HEARTMATE II, LVAS IMPLANT KIT, US, EPMEGA 8Fr. 50cc IAB (with Statlock)Patient PackLinear 7.5Fr. 34cc IABHEARTMATE 3CS100 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,INTLHVAD Pump Outflow GraftMEGA 8Fr. 50cc IABYAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)PURGE CASSETTE GEN 2, STERILE, NON QSK

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 176 active signals detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→

Post-market surveillance: a practical guide

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

→
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.