HEARTMATE 3 Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Ventricular Assist Device (LVAD)
Total Reports
169
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Modular Cable Damage Noted
equipment, exchanged, files sent, damage, modular cable
4
reports
Emergency Backup Battery Fault
backup battery, fault, ebb, emergency, faults
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in MCS
Impella
Abiomed, Inc. · 40,427 reports
HVAD Pump Implant Kit
MEDTRONIC, INC. · 37,568 reports
HeartMate 3
Thoratec Corporation · 23,083 reports
HeartMate
Thoratec Corporation · 16,395 reports
CARDIOSAVE HYBRID, TYPE B PLUG
Datascope Corp. · 13,178 reports
THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,195 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data