HEARTWARE Adverse Events: FDA MAUDE Data
Heartware Inc. · Ventricular Assist Device (LVAD)
Total Reports
1,082
Reports (30d)
14
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Patient Found Unresponsive with Asystole
passed away, emergency, low, patient passed, death
3
reports
Power Cable Damage Causing Alarms
battery, vad, batteries, device vad, low
3
reports
Driveline Sheath Damage Recurrent
normal, vad, device vad, cable, remains
2
reports
Sustained Ventricular Arrhythmia Treatment
requiring, data registry, vad, patients, device vad
2
reports
Bloodstream Infection Requiring Intervention
data registry, vad, device vad, clinical outcomes, previously received
1
reports
Right VAD Implantation Due to Failure
thrombosis, valve, vad, implantation, patients
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in MCS
Impella
Abiomed, Inc. · 42,167 reports
HVAD Pump Implant Kit
MEDTRONIC, INC. · 37,599 reports
HeartMate 3
Thoratec Corporation · 23,639 reports
HeartMate
Thoratec Corporation · 16,451 reports
CARDIOSAVE HYBRID, TYPE B PLUG
Datascope Corp. · 13,331 reports
THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,216 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data