MERIT MEDICAL SYSTEMS, INC.

Manufacturer adverse-event records for MERIT MEDICAL SYSTEMS, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1994–2026 · thin-book · typical Death-code · balanced

Volume signature

MERIT MEDICAL SYSTEMS, INC. is a thinner MAUDE footprint

MERIT MEDICAL SYSTEMS, INC. accounts for 4,296 FDA MAUDE reports (#394 of 443, thin-book tercile). Death-coded event_type share is 0.68% (typical); Injury share 16.2% (balanced).

What the volume reading shows for MERIT MEDICAL SYSTEMS, INC.

The standout signal for MERIT MEDICAL SYSTEMS, INC. is filing volume: 4,296 adverse-event reports in FDA MAUDE (#394 of 443, thin-book). Death-coded event_type share sits at 0.68% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 3,510 (81.7% of event_type total). Peak single-year volume reaches 548 reports across 33 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,296
Total Reports
29
Event-type Death
697
Injury Reports
20
Device Types

Event Types

Malfunction 3,510 (81.7%)
Injury 697 (16.2%)
Other 55 (1.3%)
Death 29 (0.7%)
5 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,511 (78.4%)
Required Intervention 500 (11.2%)
Life Threatening 128 (2.9%)
R 124 (2.8%)
Hospitalization 79 (1.8%)
Other 46 (1.0%)
L 40 (0.9%)
Death 25 (0.6%)
H 10 (0.2%)
O 10 (0.2%)
S 4 (0.1%)
Disability 2 (0.0%)

Yearly Trend

94
1994: 1
95
1995: 2
96
1996: 1
97
1997: 7
98
1998: 5
99
1999: 3
00
2000: 7
01
2001: 22
02
2002: 24
03
2003: 44
04
2004: 96
05
2005: 101
06
2006: 66
07
2007: 72
08
2008: 98
09
2009: 265
10
2010: 548
11
2011: 539
12
2012: 322
13
2013: 314
14
2014: 331
15
2015: 169
16
2016: 29
17
2017: 159
18
2018: 142
19
2019: 133
20
2020: 57
21
2021: 69
22
2022: 100
23
2023: 91
24
2024: 82
25
2025: 338
26
2026: 59