ABIOMED, INC.
Manufacturer adverse-event records for ABIOMED, 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 · 1996–2026 · heavy-book · elevated Death-code · balanced
Death-code intensity
ABIOMED, INC. carries an elevated Death-code share
Death-coded event_type rows are 4,255 of 34,735 (12.25% · elevated tercile among 434 manufacturers). Absolute volume is heavy-book.
What the Death-code reading shows for ABIOMED, INC.
The standout signal for ABIOMED, INC. is Death-code intensity: 12.25% of 34,735 reports (elevated tercile), while absolute volume is heavy-book.
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABIOMED, 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 18 device types, led in this extract by Injury at 16,747 (48.2% of event_type total). Peak single-year volume reaches 18,454 reports across 31 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 (18)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.