MEDTRONIC IRELAND

FDA MAUDE device safety record · 2002–2026

What the Data Shows About MEDTRONIC IRELAND

MEDTRONIC IRELAND is associated with 63,271 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2026. Of the total, 6,451 are coded as death reports and 32,497 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 IRELAND 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 32,497 reports (51.4% 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 25 years of MAUDE data, with the peak single-year volume reaching 5,748 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.

63,271
Total Reports
6,451
Death Reports
32,497
Injury Reports
20
Device Types

Event Types

Injury 32,497 (51.4%)
Malfunction 24,303 (38.4%)
Death 6,451 (10.2%)
14 (0.0%)
Other 6 (0.0%)

Patient Outcomes

25,492 (34.2%)
Required Intervention 21,599 (29.0%)
R 6,417 (8.6%)
Death 6,254 (8.4%)
Hospitalization 6,174 (8.3%)
Other 2,367 (3.2%)
H 1,928 (2.6%)
L 1,385 (1.9%)
O 1,218 (1.6%)
Life Threatening 1,191 (1.6%)
D 271 (0.4%)
S 125 (0.2%)
Disability 43 (0.1%)
Congenital Anomaly 15 (0.0%)
C 1 (0.0%)

Yearly Trend

02
2002: 2
03
2003: 9
04
2004: 17
05
2005: 17
06
2006: 19
07
2007: 141
08
2008: 34
09
2009: 3
10
2010: 4
11
2011: 2,385
12
2012: 3,587
13
2013: 3,139
14
2014: 3,672
15
2015: 3,716
16
2016: 2,829
17
2017: 3,374
18
2018: 4,834
19
2019: 5,378
20
2020: 4,559
21
2021: 4,617
22
2022: 4,463
23
2023: 4,822
24
2024: 4,847
25
2025: 5,748
26
2026: 1,055

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.