ABIOMED, INC. - 1220648

Manufacturer adverse-event records for ABIOMED, INC. - 1220648 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 · 2025–2026 · thin-book · elevated Death-code · injury-heavy

Death-code intensity

ABIOMED, INC. - 1220648 carries an elevated Death-code share

Death-coded event_type rows are 677 of 3,591 (18.85% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for ABIOMED, INC. - 1220648

The standout signal for ABIOMED, INC. - 1220648 is Death-code intensity: 18.85% of 3,591 reports (elevated tercile), while absolute volume is thin-book.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 5 device types, led in this extract by Injury at 2,039 (56.8% of event_type total). Peak single-year volume reaches 3,247 reports across 2 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,591
Total Reports
677
Event-type Death
2,039
Injury Reports
5
Device Types

Event Types

Injury 2,039 (56.8%)
Malfunction 875 (24.4%)
Death 677 (18.9%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 1,824 (50.0%)
806 (22.1%)
Death 400 (11.0%)
Other 215 (5.9%)
R 170 (4.7%)
D 152 (4.2%)
L 30 (0.8%)
Life Threatening 21 (0.6%)
O 14 (0.4%)
Hospitalization 7 (0.2%)
H 5 (0.1%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

25
2025: 344
26
2026: 3,247