LIVANOVA USA, INC.

Manufacturer adverse-event records for LIVANOVA USA, 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 · 2001–2026 · mid-book · elevated Death-code · balanced

Death-code intensity

LIVANOVA USA, INC. carries an elevated Death-code share

Death-coded event_type rows are 347 of 9,793 (3.54% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for LIVANOVA USA, INC.

The standout signal for LIVANOVA USA, INC. is Death-code intensity: 3.54% of 9,793 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 LIVANOVA USA, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 17 device types, led in this extract by Malfunction at 5,591 (57.1% of event_type total). Peak single-year volume reaches 1,561 reports across 24 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,793
Total Reports
347
Event-type Death
3,853
Injury Reports
17
Device Types

Event Types

Malfunction 5,591 (57.1%)
Injury 3,853 (39.3%)
Death 347 (3.5%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

4,905 (46.8%)
Required Intervention 2,269 (21.6%)
Other 1,572 (15.0%)
Hospitalization 540 (5.1%)
R 349 (3.3%)
Death 336 (3.2%)
O 193 (1.8%)
Disability 100 (1.0%)
H 92 (0.9%)
Life Threatening 58 (0.6%)
S 35 (0.3%)
L 27 (0.3%)
D 11 (0.1%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

01
2001: 1
04
2004: 1
05
2005: 1
06
2006: 1
07
2007: 4
08
2008: 8
09
2009: 8
10
2010: 8
11
2011: 16
12
2012: 35
13
2013: 37
14
2014: 52
15
2015: 65
16
2016: 89
17
2017: 186
18
2018: 1,208
19
2019: 1,561
20
2020: 1,140
21
2021: 1,203
22
2022: 1,205
23
2023: 1,148
24
2024: 973
25
2025: 766
26
2026: 77