ATRIUM MEDICAL CORPORATION

Manufacturer adverse-event records for ATRIUM MEDICAL CORPORATION 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 · 1997–2026 · thin-book · elevated Death-code · injury-heavy

Injury-mix signature

ATRIUM MEDICAL CORPORATION leans injury-heavy in event_type mix

Injury-coded event_type share is 83.0% (injury-heavy tercile) beside 1.39% Death-coded (elevated). Volume band: thin.

What the Injury-mix reading shows for ATRIUM MEDICAL CORPORATION

The standout signal for ATRIUM MEDICAL CORPORATION is Injury-mix: 83.0% Injury-coded (injury-heavy) beside 1.39% Death-coded, on a thin-book footprint.

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 18 device types, led in this extract by Injury at 4,947 (83.0% of event_type total). Peak single-year volume reaches 1,480 reports across 25 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,957
Total Reports
83
Event-type Death
4,947
Injury Reports
18
Device Types

Event Types

Injury 4,947 (83.0%)
Malfunction 903 (15.2%)
Death 83 (1.4%)
15 (0.3%)
Other 9 (0.2%)

Patient Outcomes

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

Required Intervention 4,968 (82.9%)
807 (13.5%)
Other 70 (1.2%)
Death 69 (1.2%)
R 25 (0.4%)
Life Threatening 17 (0.3%)
Hospitalization 14 (0.2%)
S 8 (0.1%)
O 5 (0.1%)
L 4 (0.1%)
Disability 3 (0.1%)
H 2 (0.0%)

Yearly Trend

97
1997: 5
03
2003: 1
04
2004: 2
05
2005: 7
06
2006: 2
07
2007: 3
08
2008: 2
09
2009: 2
10
2010: 4
11
2011: 9
12
2012: 14
13
2013: 30
14
2014: 73
15
2015: 213
16
2016: 264
17
2017: 173
18
2018: 121
19
2019: 1,168
20
2020: 1,480
21
2021: 1,331
22
2022: 438
23
2023: 205
24
2024: 256
25
2025: 136
26
2026: 18