Device manufacturer, as written on reports

Terumo Cardiovascular System: medical device reports filed with FDA

1,956 reports name it as the manufacturer of the device involved, 2010–2021.

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.

1,956
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99.1%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

1,956 medical device reports received by FDA give Terumo Cardiovascular System as the manufacturer of the device involved, 0% of the MAUDE database, from October 2010 to December 2021. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (99.1%), injury (0.5%) and death (0.3%). 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	579	0	0.2%
Terumo Cdi 500 Blood Parameter Monitor	Monitor, blood-gas, on-line, cardiopulmonary bypass	531	0	0%
Terumo Perfusion System 8000	Console, heart-lung machine, cardiopulmonary bypass	180	0	0.2%
Terumo Cdi 540 Calibrator	Monitor, blood-gas, on-line, cardiopulmonary bypass	93	0	0%
Dual Cooler/Heater	Controller, temperature, cardiopulmonary bypass	69	0	0%
Terumo Centrifugal System	Control, pump speed, cardiopulmonary bypass	56	0	0.4%
Hx2 Temperature Management System	Controller, temperature, cardiopulmonary bypass	40	0	0.7%
Terumo Cdi 100 Monitor	Sensor, blood-gas, in-line, cardiopulmonary bypass	26	0	0%
Advanced Perfusion System 1	Console, heart-lung machine, cardiopulmonary bypass	16	325	0.1%
Sarns Centrifugal Pump	Pump, blood, cardiopulmonary bypass, non-roller type	5	0	1.1%
Shunt Sensor Sys500	Monitor, blood-gas, on-line, cardiopulmonary bypass	4	0	0.1%
Sterile Fx25rec W/Res	Oxygenator, cardiopulmonary bypass	3	0	1.4%
Cardiovascular Procedure Kit	Cardiovascular procedure kit	2	0	1.3%
Bulk Non Ster Xcoat Delph Pump	Pump, blood, cardiopulmonary bypass, non-roller type	1	0	0.4%
Cdi Blood Parameter Monitoring System 500	Monitor, blood-gas, on-line, cardiopulmonary bypass	1	0	0%
Terumo	Dialyzer, capillary, hollow fiber	1	0	2.8%
Terumo Virtuosaph Vein Harvesting System	Laparoscope, general & plastic surgery	1	0	0%

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	720	36.8%
DRY	Monitor, blood-gas, on-line, cardiopulmonary bypass	637	32.6%
DWC	Controller, temperature, cardiopulmonary bypass	253	12.9%
GFA	Blade, saw, general & plastic surgery, surgical	87	4.4%
DWA	Control, pump speed, cardiopulmonary bypass	71	3.6%
JOR	Generator, pulsatile flow, cardiopulmonary bypass	60	3.1%
DTY	Sensor, blood-gas, in-line, cardiopulmonary bypass	44	2.2%
DWB	Pump, blood, cardiopulmonary bypass, roller type	36	1.8%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	17	0.9%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	11	0.6%

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

Death0.3%6

Injury0.5%9

Malfunction99.1%1,938

Other0%0

Not given0.2%3

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 System reports

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

1,956 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Terumo Advanced Perfusion System 1 (579), Terumo Cdi 500 Blood Parameter Monitor (531), Terumo Perfusion System 8000 (180), Terumo Cdi 540 Calibrator (93) and Dual Cooler/Heater (69).

Which device types does it report on?

console, heart-lung machine, cardiopulmonary bypass (36.8%), monitor, blood-gas, on-line, cardiopulmonary bypass (32.6%), controller, temperature, cardiopulmonary bypass (12.9%) and blade, saw, general & plastic surgery, surgical (4.4%).

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.