ICU MEDICAL, INC.

Manufacturer adverse-event records for ICU MEDICAL, 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 · 1992–2026 · mid-book · typical Death-code · injury-light

Injury-mix signature

ICU MEDICAL, INC. is lighter on Injury codes

Injury-coded event_type share is 1.8% (injury-light tercile) beside 0.25% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for ICU MEDICAL, INC.

The standout signal for ICU MEDICAL, INC. is Injury-mix: 1.8% Injury-coded (injury-light) beside 0.25% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ICU MEDICAL, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 9,509 (95.4% of event_type total). Peak single-year volume reaches 6,615 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,968
Total Reports
25
Event-type Death
180
Injury Reports
20
Device Types

Event Types

Malfunction 9,509 (95.4%)
Other 196 (2.0%)
Injury 180 (1.8%)
58 (0.6%)
Death 25 (0.3%)

Patient Outcomes

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

8,970 (90.5%)
Other 703 (7.1%)
Required Intervention 125 (1.3%)
Death 26 (0.3%)
Life Threatening 25 (0.3%)
R 21 (0.2%)
Hospitalization 15 (0.2%)
O 12 (0.1%)
L 9 (0.1%)
H 5 (0.1%)
D 2 (0.0%)
Disability 1 (0.0%)

Yearly Trend

92
1992: 3
94
1994: 6
95
1995: 9
96
1996: 7
97
1997: 32
98
1998: 39
99
1999: 36
00
2000: 32
01
2001: 15
02
2002: 30
03
2003: 27
04
2004: 9
05
2005: 14
06
2006: 6
07
2007: 9
08
2008: 4
09
2009: 5
10
2010: 58
11
2011: 76
12
2012: 28
13
2013: 115
14
2014: 139
15
2015: 157
16
2016: 266
17
2017: 178
18
2018: 25
19
2019: 78
20
2020: 78
21
2021: 71
22
2022: 107
23
2023: 83
24
2024: 311
25
2025: 6,615
26
2026: 1,300