CYBERONICS - HOUSTON

FDA MAUDE device safety record · 2015–2025

What the Data Shows About CYBERONICS - HOUSTON

CYBERONICS - HOUSTON is associated with 6,908 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2025. Of the total, 437 are coded as death reports and 3,075 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 3 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CYBERONICS - HOUSTON should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 3,396 reports (49.2% 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 11 years of MAUDE data, with the peak single-year volume reaching 960 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.

6,908
Total Reports
437
Death Reports
3,075
Injury Reports
3
Device Types

Event Types

Malfunction 3,396 (49.2%)
Injury 3,075 (44.5%)
Death 437 (6.3%)

Patient Outcomes

3,250 (44.6%)
Required Intervention 1,654 (22.7%)
Other 1,057 (14.5%)
Death 434 (6.0%)
Hospitalization 382 (5.2%)
R 245 (3.4%)
Disability 91 (1.2%)
O 63 (0.9%)
H 41 (0.6%)
Life Threatening 34 (0.5%)
L 19 (0.3%)
S 9 (0.1%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

15
2015: 286
16
2016: 734
17
2017: 722
18
2018: 858
19
2019: 960
20
2020: 625
21
2021: 648
22
2022: 485
23
2023: 715
24
2024: 622
25
2025: 253

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.