PlainHospital

TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer adverse-event records for TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 · 1999–2025 · mid-book · typical Death-code · injury-light

Injury-mix signature

TERUMO CARDIOVASCULAR SYSTEMS CORP. is lighter on Injury codes

Injury-coded event_type share is 1.7% (injury-light tercile) beside 0.23% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for TERUMO CARDIOVASCULAR SYSTEMS CORP.

The standout signal for TERUMO CARDIOVASCULAR SYSTEMS CORP. is Injury-mix: 1.7% Injury-coded (injury-light) beside 0.23% 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 CORP.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 12,632 (96.0% of event_type total). Peak single-year volume reaches 2,722 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

13,164
Total Reports
30
Event-type Death
226
Injury Reports
20
Device Types

Event Types

Malfunction 12,632 (96.0%)
Injury 226 (1.7%)
202 (1.5%)
Other 74 (0.6%)
Death 30 (0.2%)

Patient Outcomes

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

12,774 (96.8%)
Required Intervention 262 (2.0%)
Other 69 (0.5%)
Death 29 (0.2%)
Life Threatening 21 (0.2%)
R 20 (0.2%)
Hospitalization 8 (0.1%)
L 5 (0.0%)
O 3 (0.0%)
H 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Devices (20)

Device Reports
Console, Heart-Lung Machine, Cardiopulmonary Bypass 5,642
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 2,847
Controller, Temperature, Cardiopulmonary Bypass 1,227
Oxygenator, Cardiopulmonary Bypass 529
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 505
Blade, Saw, General & Plastic Surgery, Surgical 382
Laparoscope, General & Plastic Surgery 357
Control, Pump Speed, Cardiopulmonary Bypass 322
Generator, Pulsatile Flow, Cardiopulmonary Bypass 296
Pump, Blood, Cardiopulmonary Bypass, Roller Type 255
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass 239
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 159
Detector, Bubble, Cardiopulmonary Bypass 65
Reservoir, Blood, Cardiopulmonary Bypass 53
Cardiovascular Procedure Kit 52
Stabilizer, Heart 39
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 36
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass 32
Blade, Saw, Surgical, Cardiovascular 31
Heat-Exchanger, Cardiopulmonary Bypass 31

Yearly Trend

99
1999: 1
00
2000: 1
01
2001: 5
02
2002: 14
03
2003: 24
04
2004: 56
05
2005: 134
06
2006: 467
07
2007: 552
08
2008: 617
09
2009: 609
10
2010: 2,335
11
2011: 2,722
12
2012: 1,096
13
2013: 1,025
14
2014: 1,184
15
2015: 1,133
16
2016: 832
17
2017: 340
18
2018: 1
19
2019: 2
20
2020: 3
21
2021: 2
22
2022: 5
23
2023: 1
24
2024: 2
25
2025: 1

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