MEDTRONIC MINIMED

FDA MAUDE device safety record · 2002–2026

What the Data Shows About MEDTRONIC MINIMED

MEDTRONIC MINIMED is associated with 423,268 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2026. Of the total, 1,566 are coded as death reports and 65,145 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 MINIMED 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 356,250 reports (84.2% 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 25 years of MAUDE data, with the peak single-year volume reaching 72,443 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.

423,268
Total Reports
1,566
Death Reports
65,145
Injury Reports
20
Device Types

Event Types

Malfunction 356,250 (84.2%)
Injury 65,145 (15.4%)
Death 1,566 (0.4%)
286 (0.1%)
Other 21 (0.0%)

Patient Outcomes

363,196 (85.4%)
Hospitalization 29,746 (7.0%)
Other 23,814 (5.6%)
Required Intervention 4,347 (1.0%)
Death 1,532 (0.4%)
O 905 (0.2%)
R 719 (0.2%)
H 518 (0.1%)
Life Threatening 296 (0.1%)
L 105 (0.0%)
S 62 (0.0%)
Disability 55 (0.0%)
D 29 (0.0%)
Congenital Anomaly 6 (0.0%)

Yearly Trend

02
2002: 7
03
2003: 52
04
2004: 1,830
05
2005: 2,434
06
2006: 2,374
07
2007: 2,461
08
2008: 2,127
09
2009: 3,405
10
2010: 3,591
11
2011: 3,303
12
2012: 3,725
13
2013: 5,916
14
2014: 41,496
15
2015: 37,677
16
2016: 25,757
17
2017: 25,855
18
2018: 13,869
19
2019: 9,839
20
2020: 6,338
21
2021: 4,494
22
2022: 30,584
23
2023: 66,232
24
2024: 48,518
25
2025: 72,443
26
2026: 8,941

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.