HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD)
Total Reports
5,724
Reports (30d)
0
Active Signals
0
Open Recalls
69
What the reports describe · Claripulse analysis
Most commonly reported problems
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
7
reports
Pump Pocket Infection Post-VAD Exchange
ventricular assist, infection, vad, patients, device vad
6
reports
Driveline Sheath Damage at Repair Site
repair, vad, use, vad remains, remains
4
reports
Unexpected Death with Device Remains
vad remains, assist device, ventricular assist, data registry, device vad
4
reports
Unknown Cause of Patient Death
device therapy, passed away, therapy related, outcome, patient passed
3
reports
Multisystem Organ Failure Post-VAD Implant
adverse, left, right, vad, patients
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Keep exploring
Related devices in MCS
Impella
Abiomed, Inc. · 44,096 reports
HVAD PUMP IMPLANT KIT
MEDTRONIC, INC. · 33,490 reports
HeartMate 3
Thoratec Corporation · 24,385 reports
HeartMate
Thoratec Corporation · 16,874 reports
CARDIOSAVE HYBRID, TYPE B PLUG
Datascope Corp. · 13,675 reports
THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,254 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