TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

Manufacturer adverse-event records for TERUMO CARDIOVASCULAR SYSTEMS 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 · 2000–2026 · thin-book · typical Death-code · injury-light

Injury-mix signature

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION is lighter on Injury codes

Injury-coded event_type share is 4.6% (injury-light tercile) beside 0.70% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

The standout signal for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION is Injury-mix: 4.6% Injury-coded (injury-light) beside 0.70% 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 20 device types, led in this extract by Malfunction at 7,242 (92.7% of event_type total). Peak single-year volume reaches 1,049 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

7,810
Total Reports
55
Event-type Death
361
Injury Reports
20
Device Types

Event Types

Malfunction 7,242 (92.7%)
Injury 361 (4.6%)
146 (1.9%)
Death 55 (0.7%)
Other 6 (0.1%)

Patient Outcomes

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

7,155 (91.6%)
Required Intervention 313 (4.0%)
Other 242 (3.1%)
Death 54 (0.7%)
R 32 (0.4%)
O 10 (0.1%)
Hospitalization 3 (0.0%)
D 2 (0.0%)
L 2 (0.0%)
S 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

00
2000: 3
01
2001: 2
02
2002: 1
03
2003: 5
04
2004: 12
05
2005: 13
06
2006: 7
07
2007: 16
08
2008: 16
09
2009: 23
10
2010: 249
11
2011: 326
12
2012: 27
13
2013: 34
14
2014: 19
15
2015: 69
16
2016: 374
17
2017: 492
18
2018: 1,016
19
2019: 1,049
20
2020: 800
21
2021: 783
22
2022: 631
23
2023: 665
24
2024: 458
25
2025: 444
26
2026: 276