Dilator, vessel, for percutaneous catheterization: medical device reports filed with FDA

3,180 reports carry this product code, 1993–2026; 19 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.

3,180
reports with this product code: 0% of all MAUDE reports; 435
reports, 12 months to August 2026: 358 in the 12 months before; 40.9%
classified as malfunction: 62.3% across all reports; 5.8%
classified as death, as reported: 0.9% across all reports

Product code DRE is FDA's classification for "Dilator, vessel, for percutaneous catheterization" (cardiovascular panel), a class 2 device. 3,180 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to August 2026.

435 reports arrived in the 12 months to August 2026, up 22% from 358 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 injury (52.7%), malfunction (40.9%) and death (5.8%). 19 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
VersaCross Connect LAAC Access Solution	408	371	6%	22.7%
Si Avanti Plus	239	0	0.8%	66.4%
VersaCross Connect Access Solution for FARADRIVE	215	280	1.9%	45.7%
Spectranetics Tightrail Rotating Dilator Sheath	169	0	21.1%	19.9%
Micropuncture Transitionless Stiffened Cannula Access Set	44	19	0%	54.5%
Micropuncture Transitionless Access Set	42	19	0.3%	53.9%
Super Sheath Introducer Sheath	34	1	0%	78.7%
AngioDynamics	33	14	1.7%	82.2%
VersaCross Access Solution	9	144	7.9%	29.7%
Merit Custom Kit	3	13	0.1%	96.7%
Evolution Biliary Controlled-Release Stent - Fully Covered	2	99	0.2%	83.7%
Peritoneal Dialysis Catheter	2	55	2.3%	29.2%
Arrow	1	65	3.4%	66.7%
Edwards Sapien Transcatheter Heart Valve	1	7	14.3%	2.9%
Edwards SAPIEN XT Transcatheter Heart Valve	1	48	7.6%	2.4%
Flexor Raabe Guiding Sheath	1	30	1.1%	67.7%
Gore Tag Thoracic Endoprosthesis	1	4	14.7%	3.3%
RF Needle	1	64	0.6%	82.8%
Spectranetics 16f Glidelight Laser Sheath	1	0	32.7%	6.2%

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
Baylis Medical	313	9.8%
Merit Medical Systems	281	8.8%
Baylis Medicale Cie	260	8.2%
Spectranetics	220	6.9%
Cordis De Mexico	209	6.6%
Cordis	173	5.4%
The Spectranetics	161	5.1%
Cook	126	4%
Argon Medical Devices	121	3.8%
Guidant Endovascular Solutions	113	3.6%
Angiodynamics	107	3.4%
Cordis US	106	3.3%
Edwards Lifesciences	58	1.8%
Boston Scientific - Maple Grove	16	0.5%
Livanova USA	5	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 and report source

Event type

Death5.8%186

Injury52.7%1,677

Malfunction40.9%1,300

Other0.2%6

Not given0.3%11

Who filed

Manufacturer report93.6%2,978

Voluntary report3.4%108

User facility report0%0

Distributor report0.1%2

Not given2.9%92

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material separation	279	8.8%
Fracturea broken bone	258	8.1%
Breakthe device broke	206	6.5%
Detachment of device or device componentpart of the device came off	179	5.6%
Difficult to removethe device was hard to remove	162	5.1%
Physical resistance/sticking	114	3.6%
Detachment of device component	104	3.3%
Difficult to advance	104	3.3%
Positioning problem	101	3.2%
Device-device incompatibility	94	3%
Device contamination with chemical or other material	87	2.7%
Defective devicethe device was defective	81	2.5%
Obstruction of flow	78	2.5%
Material deformation	63	2%
Difficult to insertthe device was hard to insert	62	1.9%
Packaging problem	58	1.8%
Entrapment of device	49	1.5%
Tears, rips, holes in device, device material	47	1.5%
Insufficient device problem information	45	1.4%
Material perforation	39	1.2%

Questions about dilator, vessel, for percutaneous catheterization reports

What is product code DRE?

FDA's classification code for "Dilator, vessel, for percutaneous catheterization", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,180 reports through August 2026, 435 of them in the latest 12 months.

Which brands appear most often?

VersaCross Connect LAAC Access Solution (408), Si Avanti Plus (239), VersaCross Connect Access Solution for FARADRIVE (215), Spectranetics Tightrail Rotating Dilator Sheath (169) and Micropuncture Transitionless Stiffened Cannula Access Set (44). 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.