ICU MEDICAL COSTA RICA LTD.

Manufacturer adverse-event records for ICU MEDICAL COSTA RICA LTD. 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 · 2017–2026 · thin-book · elevated Death-code · injury-light

Volume signature

ICU MEDICAL COSTA RICA LTD. is a thinner MAUDE footprint

ICU MEDICAL COSTA RICA LTD. accounts for 4,447 FDA MAUDE reports (#394 of 434, thin-book tercile). Death-coded event_type share is 0.97% (elevated); Injury share 2.7% (injury-light).

What the volume reading shows for ICU MEDICAL COSTA RICA LTD.

The standout signal for ICU MEDICAL COSTA RICA LTD. is filing volume: 4,447 adverse-event reports in FDA MAUDE (#394 of 434, thin-book). Death-coded event_type share sits at 0.97% (elevated).

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 13 device types, led in this extract by Malfunction at 4,285 (96.4% of event_type total). Peak single-year volume reaches 919 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,447
Total Reports
43
Event-type Death
118
Injury Reports
13
Device Types

Event Types

Malfunction 4,285 (96.4%)
Injury 118 (2.7%)
Death 43 (1.0%)
Other 1 (0.0%)

Patient Outcomes

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

4,238 (95.1%)
Required Intervention 64 (1.4%)
Death 41 (0.9%)
Life Threatening 39 (0.9%)
R 29 (0.7%)
L 22 (0.5%)
Hospitalization 17 (0.4%)
Other 3 (0.1%)
D 2 (0.0%)
H 2 (0.0%)
S 1 (0.0%)

Yearly Trend

17
2017: 2
18
2018: 11
19
2019: 471
20
2020: 277
21
2021: 172
22
2022: 335
23
2023: 835
24
2024: 919
25
2025: 636
26
2026: 789