MEDTRONIC, INC.

FDA MAUDE device safety record · 1992–2026

What the Data Shows About MEDTRONIC, INC.

MEDTRONIC, INC. is associated with 77,710 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2026. Of the total, 1,714 are coded as death reports and 18,614 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, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 6 distinct event types appear in the record, led by Malfunction at 56,701 reports (73.0% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 14,998 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.

77,710
Total Reports
1,714
Death Reports
18,614
Injury Reports
20
Device Types

Event Types

Malfunction 56,701 (73.0%)
Injury 18,614 (24.0%)
Death 1,714 (2.2%)
Other 499 (0.6%)
180 (0.2%)
No answer provided 2 (0.0%)

Patient Outcomes

50,472 (55.4%)
Hospitalization 9,123 (10.0%)
R 9,100 (10.0%)
Other 7,533 (8.3%)
Required Intervention 7,152 (7.9%)
H 2,205 (2.4%)
L 1,810 (2.0%)
Death 1,697 (1.9%)
Life Threatening 1,384 (1.5%)
O 375 (0.4%)
S 123 (0.1%)
Disability 40 (0.0%)
D 38 (0.0%)
Congenital Anomaly 9 (0.0%)
Invalid Data 2 (0.0%)

Yearly Trend

92
1992: 8
93
1993: 25
94
1994: 178
95
1995: 123
96
1996: 231
97
1997: 501
98
1998: 259
99
1999: 236
00
2000: 344
01
2001: 459
02
2002: 513
03
2003: 106
04
2004: 183
05
2005: 249
06
2006: 202
07
2007: 163
08
2008: 379
09
2009: 451
10
2010: 1,129
11
2011: 3,702
12
2012: 4,323
13
2013: 2,192
14
2014: 3,623
15
2015: 4,611
16
2016: 2,872
17
2017: 2,201
18
2018: 2,278
19
2019: 2,337
20
2020: 3,572
21
2021: 5,042
22
2022: 4,108
23
2023: 4,351
24
2024: 6,327
25
2025: 14,998
26
2026: 5,434

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.