MEDTRONIC MEXICO

FDA MAUDE device safety record · 2011–2026

What the Data Shows About MEDTRONIC MEXICO

MEDTRONIC MEXICO is associated with 6,360 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2011 through 2026. Of the total, 136 are coded as death reports and 1,601 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC MEXICO 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 4,623 reports (72.7% 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 16 years of MAUDE data, with the peak single-year volume reaching 1,313 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.

6,360
Total Reports
136
Death Reports
1,601
Injury Reports
20
Device Types

Event Types

Malfunction 4,623 (72.7%)
Injury 1,601 (25.2%)
Death 136 (2.1%)

Patient Outcomes

4,634 (64.5%)
Required Intervention 986 (13.7%)
R 420 (5.8%)
Hospitalization 345 (4.8%)
H 187 (2.6%)
Other 165 (2.3%)
L 154 (2.1%)
Death 122 (1.7%)
Life Threatening 102 (1.4%)
O 50 (0.7%)
D 16 (0.2%)
S 4 (0.1%)
Disability 2 (0.0%)

Yearly Trend

11
2011: 3
12
2012: 28
13
2013: 48
14
2014: 117
15
2015: 186
16
2016: 169
17
2017: 297
18
2018: 467
19
2019: 520
20
2020: 519
21
2021: 362
22
2022: 452
23
2023: 1,313
24
2024: 1,261
25
2025: 613
26
2026: 5

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.