Reported Reactions

Devices › Clamp, vascular

Device brand name · Clamp vascular

Tr Band Radial Compression Device: medical device reports filed with FDA

292 reports name it, 2023–2025. Manufacturer given most often on reports: Terumo Medical. Product code DXC.

292
device reports naming the brand
0% of all MAUDE reports · about 92 a year
1
reports, 12 months to August 2026
28 in the 12 months before
69.9%
classified as malfunction
88% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 292 reports that name the brand "Tr Band Radial Compression Device" (clamp vascular), received between May 2023 and November 2025; the manufacturer given most often on reports is Terumo Medical. Spellings of one product vary from report to report.

1 reports arrived in the 12 months to August 2026, down 96% from 28 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 (69.9%), injury (29.8%) and other (0.3%); across all clamp, vascular reports (product code DXC) death is recorded in 0.6% and malfunction in 88%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are deflation problem (48.3%), gas/air leak (44.2%) and leak/splash (4.8%). The patient problems coded most often are hematoma, hemorrhage/blood loss/bleeding and pain. 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."

Reports by month, five years

061121Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 1Jun 2023: 121Jul 2023: 35Aug 2023: 6Sep 2023: 0Oct 2023: 3Nov 2023: 6Dec 2023: 92024Jan 2024: 12Feb 2024: 9Mar 2024: 15Apr 2024: 10May 2024: 11Jun 2024: 10Jul 2024: 9Aug 2024: 6Sep 2024: 11Oct 2024: 7Nov 2024: 7Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 2May 2025: 0Jun 2025: 1Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 1Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

By year received

0911812023: 18120232024: 10720242025: 42025

Event type and report source

Event type, as classified on the report

Death0%0
Injury29.8%87
Malfunction69.9%204
Other0.3%1
Not given0%0

Who filed the report

Manufacturer report98.3%287
Voluntary report1.4%4
User facility report0%0
Distributor report0%0
Not given0.3%1

Grey bar: all 13,077 reports carrying product code DXC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Deflation problem14148.3%2.7%
Gas/air leak12944.2%5.8%
Leak/splashthe device leaked144.8%1.1%
Unintended deflation82.7%2.8%
Device slipped51.7%0.5%
Failure to seal51.7%0.2%
Breakthe device broke41.4%2.3%
Filling problem41.4%0.2%
Inflation problem31%0.7%
Unintended movement31%0.1%
Activation, positioning or separation problem20.7%1.4%
Tear, rip or hole in device packaging20.7%0.1%
Failure to deflate10.3%0%
Material perforation10.3%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Hematomaa collection of blood under the skin or in tissue5418.5%
Hemorrhage/blood loss/bleeding217.2%
Painpain, site not specified51.7%
Bruise/contusion41.4%
Thrombosis/thrombus20.7%
Discomfortdiscomfort10.3%
Obstruction/occlusion10.3%
Swelling/ edema10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTr Band Radial Compression DeviceProduct code DXCAll MAUDE reports
Reports29213,07726,136,888
Share of that pool—2.2%0%
Classified as death, per 1,000 reports069
Classified as injury29.8%10.7%36.2%
Classified as malfunction69.9%88%62.3%
Filed by the manufacturer98.3%97%94.9%

Shares are of reports, not 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."

Other brands with product code DXC

BrandReportsLatest 12 monthsClassified as death
Guidant 4 5 Mm Heartstring Proximal Seal2,61700%
Tr Band1,2735710.2%
Guidant 4 5mm Heartstring Proximal Seal61500%
Endoclamp Aortic Catheter16902.4%
Acrobat-i Stabilizer424370.2%
VasoView Hemopro 26,6336860%
Vaso View Hemopro1,83800.1%
Resolution Clip Device1,59600.3%
Vasoview 6 Pro32880%
Vasoview 7 Xb38800%
HemoPro2 Extension Cable539300%
Karl Storz63302.1%
Vasoview Hemopro 2 Evh System25900%
Hemopro2 Adaptor167140%
Vasoview Hemopro 2 With Vasoshield17600%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Tr Band Radial Compression Device reports

How many FDA reports name Tr Band Radial Compression Device?

292 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.

What kinds of events are reported?

malfunction (69.9%), injury (29.8%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

deflation problem (48.3%), gas/air leak (44.2%), leak/splash (4.8%), unintended deflation (2.7%) and device slipped (1.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.3%) and voluntary reports (1.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Tr Band Radial Compression Device was at fault?

No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.