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 5,298 FDA MAUDE reports (#363 of 434, thin-book tercile). Death-coded event_type share is 0.30% (typical); Injury share 15.8% (balanced).

What the volume reading shows for GYRUS ACMI, INC.

The standout signal for GYRUS ACMI, INC. is filing volume: 5,298 adverse-event reports in FDA MAUDE (#363 of 434, thin-book). Death-coded event_type share sits at 0.30% (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 4,354 (82.2% of event_type total). Peak single-year volume reaches 1,662 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,298
Total Reports
16
Event-type Death
839
Injury Reports
20
Device Types

Event Types

Malfunction 4,354 (82.2%)
Injury 839 (15.8%)
Other 76 (1.4%)
Death 16 (0.3%)
13 (0.2%)

Patient Outcomes

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

4,410 (80.8%)
Required Intervention 510 (9.3%)
Other 155 (2.8%)
Hospitalization 120 (2.2%)
R 113 (2.1%)
H 85 (1.6%)
L 21 (0.4%)
O 16 (0.3%)
Death 13 (0.2%)
D 9 (0.2%)
Life Threatening 8 (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: 1,662
26
2026: 844