PlainHospital

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 · mid-book · typical Death-code · injury-light

Injury-mix signature

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION is lighter on Injury codes

Injury-coded event_type share is 4.7% (injury-light tercile) beside 0.70% Death-coded (typical). Volume band: mid.

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

The standout signal for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION is Injury-mix: 4.7% Injury-coded (injury-light) beside 0.70% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 7,029 (92.6% 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.

7,589
Total Reports
53
Event-type Death
355
Injury Reports
20
Device Types

Event Types

Malfunction 7,029 (92.6%)
Injury 355 (4.7%)
146 (1.9%)
Death 53 (0.7%)
Other 6 (0.1%)

Patient Outcomes

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

6,990 (91.6%)
Required Intervention 301 (3.9%)
Other 238 (3.1%)
Death 51 (0.7%)
R 32 (0.4%)
O 9 (0.1%)
Hospitalization 3 (0.0%)
D 2 (0.0%)
L 2 (0.0%)
S 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (20)

Device Reports
Console, Heart-Lung Machine, Cardiopulmonary Bypass 3,477
Oxygenator, Cardiopulmonary Bypass 1,396
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 725
Cardiovascular Procedure Kit 416
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 351
Laparoscope, General & Plastic Surgery 192
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 188
Electrosurgical, Cutting & Coagulation & Accessories 181
Pump, Blood, Cardiopulmonary Bypass, Roller Type 168
Controller, Temperature, Cardiopulmonary Bypass 161
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 98
Stabilizer, Heart 77
Control, Pump Speed, Cardiopulmonary Bypass 42
Blade, Saw, General & Plastic Surgery, Surgical 40
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass 26
Heat-Exchanger, Cardiopulmonary Bypass 14
Computer, Blood-Pressure 8
Reservoir, Blood, Cardiopulmonary Bypass 8
Accessory Equipment, Cardiopulmonary Bypass 4
Filter, Blood, Cardiopulmonary Bypass, Arterial Line 4

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: 55

Read our methodology - how this data is sourced, computed, and verified.