HEARTWARE, INC.
Manufacturer adverse-event records for HEARTWARE, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2013–2026 · heavy-book · elevated Death-code · injury-heavy
Death-code intensity
HEARTWARE, INC. carries an elevated Death-code share
Death-coded event_type rows are 6,158 of 63,385 (9.72% · elevated tercile among 434 manufacturers). Absolute volume is heavy-book.
What the Death-code reading shows for HEARTWARE, INC.
The standout signal for HEARTWARE, INC. is Death-code intensity: 9.72% of 63,385 reports (elevated tercile), while absolute volume is heavy-book.
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair HEARTWARE, INC. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 3 device types, led in this extract by Injury at 34,772 (54.9% of event_type total). Peak single-year volume reaches 14,692 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (3)
| Device | Reports |
|---|---|
| Ventricular (Assist) Bypass | 63,382 |
| Introducer, Catheter | 2 |
| Implantable Pacemaker Pulse-Generator | 1 |
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.