NEVRO CORP.

FDA MAUDE device safety record · 2017–2026

What the Data Shows About NEVRO CORP.

NEVRO CORP. is associated with 5,707 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2017 through 2026. Of the total, 930 are coded as death reports and 4,557 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 2 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for NEVRO CORP. 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 Injury at 4,557 reports (79.8% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 10 years of MAUDE data, with the peak single-year volume reaching 1,173 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.

5,707
Total Reports
930
Death Reports
4,557
Injury Reports
2
Device Types

Event Types

Injury 4,557 (79.8%)
Death 930 (16.3%)
Malfunction 217 (3.8%)
Other 2 (0.0%)
1 (0.0%)

Patient Outcomes

Other 2,114 (30.5%)
Required Intervention 1,802 (26.0%)
Death 930 (13.4%)
Hospitalization 611 (8.8%)
R 583 (8.4%)
H 510 (7.4%)
214 (3.1%)
O 93 (1.3%)
Disability 31 (0.4%)
S 25 (0.4%)
D 9 (0.1%)
L 9 (0.1%)
Life Threatening 4 (0.1%)
C 1 (0.0%)

Yearly Trend

17
2017: 121
18
2018: 419
19
2019: 517
20
2020: 427
21
2021: 579
22
2022: 618
23
2023: 793
24
2024: 1,173
25
2025: 976
26
2026: 84

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.