GYRUS ACMI, INC.

Manufacturer adverse-event records for GYRUS ACMI, 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 · 2004–2026 · thin-book · typical Death-code · balanced

Volume signature

GYRUS ACMI, INC. is a thinner MAUDE footprint

GYRUS ACMI, INC. accounts for 4,706 FDA MAUDE reports (#374 of 443, thin-book tercile). Death-coded event_type share is 0.34% (typical); Injury share 16.8% (balanced).

What the volume reading shows for GYRUS ACMI, INC.

The standout signal for GYRUS ACMI, INC. is filing volume: 4,706 adverse-event reports in FDA MAUDE (#374 of 443, thin-book). Death-coded event_type share sits at 0.34% (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 3,811 (81.0% of event_type total). Peak single-year volume reaches 1,658 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,706
Total Reports
16
Event-type Death
790
Injury Reports
20
Device Types

Event Types

Malfunction 3,811 (81.0%)
Injury 790 (16.8%)
Other 76 (1.6%)
Death 16 (0.3%)
13 (0.3%)

Patient Outcomes

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

3,945 (80.6%)
Required Intervention 487 (10.0%)
Other 147 (3.0%)
Hospitalization 99 (2.0%)
R 90 (1.8%)
H 67 (1.4%)
O 16 (0.3%)
L 13 (0.3%)
Death 13 (0.3%)
D 9 (0.2%)
Life Threatening 6 (0.1%)
S 1 (0.0%)

Yearly Trend

04
2004: 3
07
2007: 2
08
2008: 3
09
2009: 31
10
2010: 54
11
2011: 48
12
2012: 67
13
2013: 64
14
2014: 48
15
2015: 33
16
2016: 14
17
2017: 24
18
2018: 17
19
2019: 29
20
2020: 38
21
2021: 15
22
2022: 305
23
2023: 846
24
2024: 1,151
25
2025: 1,658
26
2026: 256