Device manufacturer, as written on reports

Terumo Cardiovascular Systems: medical device reports filed with FDA

22,913 reports name it as the manufacturer of the device involved, 1999–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

22,913
reports naming it as manufacturer: 0.1% of all MAUDE reports; 489
reports, 12 months to August 2026: 409 in the 12 months before; 94.6%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

22,913 medical device reports received by FDA give Terumo Cardiovascular Systems as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 1999 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

489 reports arrived in the 12 months to August 2026, up 20% from 409 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (94.6%), injury (2.8%) and death (0.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Terumo Advanced Perfusion System 1	Console, heart-lung machine, cardiopulmonary bypass	4,480	0	0.2%
Advanced Perfusion System 1	Console, heart-lung machine, cardiopulmonary bypass	3,731	325	0.1%
Terumo Cdi 500 Blood Parameter Monitor	Monitor, blood-gas, on-line, cardiopulmonary bypass	2,236	0	0%
Terumo Perfusion System 8000	Console, heart-lung machine, cardiopulmonary bypass	1,195	0	0.2%
Shunt Sensor Sys500	Monitor, blood-gas, on-line, cardiopulmonary bypass	703	0	0.1%
Cardiovascular Procedure Kit	Cardiovascular procedure kit	543	0	1.3%
Terumo Cdi 540 Calibrator	Monitor, blood-gas, on-line, cardiopulmonary bypass	507	0	0%
Terumo Advanced Perfusion System One	Console, heart-lung machine, cardiopulmonary bypass	456	0	0%
Terumo Centrifugal System	Control, pump speed, cardiopulmonary bypass	408	0	0.4%
Terumo Virtuosaph Vein Harvesting System	Laparoscope, general & plastic surgery	373	0	0%
Cdi Blood Parameter Monitoring System 500	Monitor, blood-gas, on-line, cardiopulmonary bypass	336	0	0%
Dual Cooler/Heater	Controller, temperature, cardiopulmonary bypass	289	0	0%
Sterile Fx25rec W/Res	Oxygenator, cardiopulmonary bypass	274	0	1.4%
Sterile Fx25rwc W/ Res	Oxygenator, cardiopulmonary bypass	271	0	2.5%
Bulk Non Ster Xcoat Delph Pump	Pump, blood, cardiopulmonary bypass, non-roller type	265	0	0.4%
Hx2 Temperature Management System	Controller, temperature, cardiopulmonary bypass	253	0	0.7%
Sarns Centrifugal Pump	Pump, blood, cardiopulmonary bypass, non-roller type	182	0	1.1%
Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.	Oxygenator, cardiopulmonary bypass	160	68	6.3%
Terumo Cdi 100 Monitor	Sensor, blood-gas, in-line, cardiopulmonary bypass	153	0	0%
Sarns 8000 Perfusion System	Console, heart-lung machine, cardiopulmonary bypass	152	0	0%
Terumo Cardiovascular Procedure Kit	Cardiovascular procedure kit	84	24	0.7%
Capiox Fx Oxygenator	Oxygenator, cardiopulmonary bypass	7	0	1.5%
Terumo	Dialyzer, capillary, hollow fiber	5	0	2.8%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
DTQ	Console, heart-lung machine, cardiopulmonary bypass	9,949	43.4%
DRY	Monitor, blood-gas, on-line, cardiopulmonary bypass	4,141	18.1%
DTZ	Oxygenator, cardiopulmonary bypass	1,995	8.7%
DWC	Controller, temperature, cardiopulmonary bypass	1,536	6.7%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	816	3.6%
GCJ	Laparoscope, general & plastic surgery	598	2.6%
OEZ	Cardiovascular procedure kit	471	2.1%
GFA	Blade, saw, general & plastic surgery, surgical	463	2%
DWB	Pump, blood, cardiopulmonary bypass, roller type	434	1.9%
DWA	Control, pump speed, cardiopulmonary bypass	375	1.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.4%100

Injury2.8%646

Malfunction94.6%21,670

Other0.4%94

Not given1.8%403

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Terumo Cardiovascular Systems reports

How many FDA device reports name Terumo Cardiovascular Systems as manufacturer?

22,913 reports through August 2026, 489 of them in the latest 12 months.

Which of its brands appear most often?

Terumo Advanced Perfusion System 1 (4,480), Advanced Perfusion System 1 (3,731), Terumo Cdi 500 Blood Parameter Monitor (2,236), Terumo Perfusion System 8000 (1,195) and Shunt Sensor Sys500 (703).

Which device types does it report on?

console, heart-lung machine, cardiopulmonary bypass (43.4%), monitor, blood-gas, on-line, cardiopulmonary bypass (18.1%), oxygenator, cardiopulmonary bypass (8.7%) and controller, temperature, cardiopulmonary bypass (6.7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.