Device manufacturer, as written on reports

Terumo Medical: medical device reports filed with FDA

13,208 reports name it as the manufacturer of the device involved, 1992–2026.

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.

13,208
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,452
reports, 12 months to August 2026: 1,183 in the 12 months before; 55.9%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

13,208 medical device reports received by FDA give Terumo Medical as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,452 reports arrived in the 12 months to August 2026, up 23% from 1,183 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 (55.9%), injury (43.5%) 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
6f Angio-Seal Vip Vascular Closure Device Ous	Device, hemostasis, vascular	1,818	0	0.3%
Angio-Seal	Device, hemostasis, vascular	1,708	902	0.8%
6f Angio-Seal Vip Vascular Closure Device Us	Device, hemostasis, vascular	1,615	0	0.2%
8f Angio-Seal Vip Vascular Closure Device Ous	Device, hemostasis, vascular	1,056	0	0.3%
Tr Band	Clamp, vascular	929	571	0.2%
8f Angio-Seal Sts Plus Vascular Closure Device Ous	Device, hemostasis, vascular	619	0	0.2%
Glidesheath Slender	Introducer, catheter	533	95	0%
8f Angio-Seal Vip Vascular Closure Device Us	Device, hemostasis, vascular	366	0	0.8%
6f Angio-Seal Sts Plus Vascular Closure Device Ous	Device, hemostasis, vascular	322	0	0%
6f Angio-Seal Evolution Vascular Closure Device Us	Device, hemostasis, vascular	302	0	0.3%
Tr Band Radial Compression Device	Clamp, vascular	292	1	0%
R2p Destination Slender Guiding Sheath	Introducer, catheter	231	0	0.4%
6f Angio-Seal Evolution Vascular Closure Device Ous	Device, hemostasis, vascular	188	0	0%
Pinnacle	Impactor	39	499	0.1%
Runthrough Ns	Wire, guide, catheter	35	0	1.9%
Capiox Fx Oxygenator	Oxygenator, cardiopulmonary bypass	28	0	1.5%
Terumo	Dialyzer, capillary, hollow fiber	18	0	2.8%
Radifocus Guidewire M	Wire, guide, catheter	15	3	1.4%
Radifocus Glidewire	Wire, guide, catheter	9	25	2.1%
Dialyzer	Dialyzer, high permeability with or without sealed dialysate system	5	69	2.2%
Angio-Seal Vip Vascular Closure Device	Device, hemostasis, vascular	4	0	3.4%
Ni	Set, administration, for peritoneal dialysis, disposable	1	1,587	1.8%
Sarns Centrifugal Pump	Pump, blood, cardiopulmonary bypass, non-roller type	1	0	1.1%

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
MGB	Device, hemostasis, vascular	8,762	66.3%
DYB	Introducer, catheter	2,424	18.4%
DXC	Clamp, vascular	1,263	9.6%
DQX	Wire, guide, catheter	232	1.8%
DTZ	Oxygenator, cardiopulmonary bypass	126	1%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	80	0.6%
FMF	Syringe, piston	66	0.5%
DQO	Catheter, intravascular, diagnostic	38	0.3%
OCY	Endoscopic guidewire, gastroenterology-urology	38	0.3%
FMI	Needle, hypodermic, single lumen	31	0.2%

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%51

Injury43.5%5,743

Malfunction55.9%7,380

Other0.1%13

Not given0.2%21

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

Questions about Terumo Medical reports

How many FDA device reports name Terumo Medical as manufacturer?

13,208 reports through August 2026, 1,452 of them in the latest 12 months.

Which of its brands appear most often?

6f Angio-Seal Vip Vascular Closure Device Ous (1,818), Angio-Seal (1,708), 6f Angio-Seal Vip Vascular Closure Device Us (1,615), 8f Angio-Seal Vip Vascular Closure Device Ous (1,056) and Tr Band (929).

Which device types does it report on?

device, hemostasis, vascular (66.3%), introducer, catheter (18.4%), clamp, vascular (9.6%) and wire, guide, catheter (1.8%).

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.