HEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINE Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Ventricular Assist Device (LVAD)

Total Reports

2,342

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Regulatory

FDA recalls for this device

Class II

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

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Keep exploring

Related devices in MCS

Impella

Abiomed, Inc. · 39,669 reports

→

HVAD Pump Implant Kit

MEDTRONIC, INC. · 37,288 reports

→

HeartMate 3

Thoratec Corporation · 22,735 reports

→

HeartMate

Thoratec Corporation · 16,160 reports

→

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 13,030 reports

→

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,171 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 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.

→

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.