Clamp, vascular: medical device reports filed with FDA

13,077 reports carry this product code, 1994–2026; 27 brands with a page.

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.

13,077
reports with this product code: 0.1% of all MAUDE reports; 811
reports, 12 months to August 2026: 444 in the 12 months before; 88%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code DXC is FDA's classification for "Clamp, vascular" (cardiovascular panel), a class 2 device. 13,077 medical device reports carry this product code, 0.1% of the MAUDE database, from February 1994 to August 2026.

811 reports arrived in the 12 months to August 2026, up 83% from 444 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 (88%), injury (10.7%) and death (0.6%). 27 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Guidant 4 5 Mm Heartstring Proximal Seal	2,617	0	0%	92.1%
Tr Band	1,269	571	0.2%	82.8%
Guidant 4 5mm Heartstring Proximal Seal	615	0	0%	90.4%
Tr Band Radial Compression Device	292	1	0%	69.9%
Endoclamp Aortic Catheter	99	0	2.4%	72.8%
Acrobat-i Stabilizer	56	37	0.2%	98.3%
VasoView Hemopro 2	28	686	0%	92.6%
Vaso View Hemopro	17	0	0.1%	86.7%
Resolution Clip Device	12	0	0.3%	90.3%
Vasoview 6 Pro	7	8	0%	94.5%
Vasoview 7 Xb	7	0	0%	90.2%
HemoPro2 Extension Cable	4	30	0%	98.5%
Karl Storz	4	0	2.1%	24.6%
Vasoview Hemopro 2 Evh System	4	0	0%	82.6%
Hemopro2 Adaptor	3	14	0%	97%
Vasoview Hemopro 2 With Vasoshield	3	0	0%	90.9%
Asku	2	210	1.1%	47.1%
Guidant Vasoview 5 Harvesting Cannula	2	0	0.3%	87.2%
Ni	2	1,587	1.8%	29.5%
Starclose Vascular Closure System	2	8	1.2%	46%
Vasoview Hemopro	2	0	0%	85.3%
Bom 7mm Extended Length Endoscope	1	0	0%	97.6%
Dc Extension Cable	1	0	0%	98.9%
Perclose ProGlide	1	653	0.9%	16.1%
Resolution Clip	1	36	0.1%	98.3%
S5 Gas Blender System	1	0	0%	90.6%
Vasoviewhempro Vh-3500	1	0	0%	86.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Maquet Cardiovascular	5,164	39.5%
Guidant Cardiac Surgery	3,484	26.6%
Terumo Medical	1,263	9.7%
Maquet Cv	948	7.2%
Edwards Lifesciences	275	2.1%
Terumo Ashitaka	177	1.4%
Applied Medical Resources	154	1.2%
Livanova Deutschland	148	1.1%
Synovis Surgical Innovations	87	0.7%
Edwards Lifesciences Pr	83	0.6%
Ethicon	38	0.3%
Merit Medical Systems	23	0.2%
St Jude Medical	18	0.1%
Applied Medical	15	0.1%
St Jude Medical Puerto Rico	12	0.1%

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 and report source

Event type

Death0.6%78

Injury10.7%1,394

Malfunction88%11,512

Other0.4%58

Not given0.3%35

Who filed

Manufacturer report97%12,682

Voluntary report1.1%145

User facility report0%0

Distributor report0.2%27

Not given1.7%223

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Replace	2,473	18.9%
Crackthe device cracked	2,292	17.5%
Positioning failure	1,793	13.7%
Fitting problem	1,413	10.8%
Device operates differently than expectedthe device behaved unexpectedly	1,078	8.2%
Gas/air leak	760	5.8%
Unraveled material	443	3.4%
Activation problem	424	3.2%
Sticking	376	2.9%
Unintended deflation	371	2.8%
Deflation problem	359	2.7%
Breakthe device broke	307	2.3%
Failure to advance	281	2.1%
Device difficult to setup or prepare	274	2.1%
Failure to unfold or unwrap	221	1.7%
Difficult to removethe device was hard to remove	211	1.6%
Activation, positioning or separation problem	189	1.4%
Detachment of device component	164	1.3%
Air leak	156	1.2%
Difficult to open or close	147	1.1%

Questions about clamp, vascular reports

What is product code DXC?

FDA's classification code for "Clamp, vascular", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

13,077 reports through August 2026, 811 of them in the latest 12 months.

Which brands appear most often?

Guidant 4 5 Mm Heartstring Proximal Seal (2,617), Tr Band (1,269), Guidant 4 5mm Heartstring Proximal Seal (615), Tr Band Radial Compression Device (292) and Endoclamp Aortic Catheter (99). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.