LIVANOVA DEUTSCHLAND

FDA MAUDE device safety record · 2015–2026

What the Data Shows About LIVANOVA DEUTSCHLAND

LIVANOVA DEUTSCHLAND is associated with 6,113 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2026. Of the total, 145 are coded as death reports and 272 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 12 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for LIVANOVA DEUTSCHLAND should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 5,665 reports (92.7% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 906 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

6,113
Total Reports
145
Death Reports
272
Injury Reports
12
Device Types

Event Types

Malfunction 5,665 (92.7%)
Injury 272 (4.4%)
Death 145 (2.4%)
30 (0.5%)
Other 1 (0.0%)

Patient Outcomes

5,702 (90.8%)
Death 137 (2.2%)
O 132 (2.1%)
Other 124 (2.0%)
Life Threatening 106 (1.7%)
Hospitalization 27 (0.4%)
L 21 (0.3%)
R 12 (0.2%)
D 7 (0.1%)
Required Intervention 5 (0.1%)
H 4 (0.1%)
S 3 (0.0%)
Disability 1 (0.0%)

Yearly Trend

15
2015: 8
16
2016: 60
17
2017: 906
18
2018: 868
19
2019: 890
20
2020: 427
21
2021: 752
22
2022: 687
23
2023: 519
24
2024: 403
25
2025: 562
26
2026: 31

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.