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 · mid-book · elevated Death-code · balanced

Death-code intensity

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

Death-coded event_type rows are 1,657 of 9,756 (16.98% · elevated tercile among 434 manufacturers). Absolute volume is mid-book.

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

The standout signal for ABIOMED, INC. - 1220648 is Death-code intensity: 16.98% of 9,756 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ABIOMED, INC. - 1220648. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 6 device types, led in this extract by Injury at 4,612 (47.3% of event_type total). Peak single-year volume reaches 9,411 reports across 2 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,756
Total Reports
1,657
Event-type Death
4,612
Injury Reports
6
Device Types

Event Types

Injury 4,612 (47.3%)
Malfunction 3,487 (35.7%)
Death 1,657 (17.0%)

Patient Outcomes

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

Required Intervention 3,966 (40.2%)
3,201 (32.5%)
Death 1,135 (11.5%)
Other 548 (5.6%)
R 448 (4.5%)
D 417 (4.2%)
O 47 (0.5%)
L 44 (0.4%)
Life Threatening 37 (0.4%)
Hospitalization 8 (0.1%)
H 6 (0.1%)
Disability 2 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

25
2025: 345
26
2026: 9,411