Wire, guide, catheter: medical device reports filed with FDA

33,838 reports carry this product code, 1992–2026; 30 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.

33,838
reports with this product code: 0.1% of all MAUDE reports; 2,117
reports, 12 months to August 2026: 2,176 in the 12 months before; 57.4%
classified as malfunction: 62.3% across all reports; 2.8%
classified as death, as reported: 0.9% across all reports

Product code DQX is FDA's classification for "Wire, guide, catheter" (cardiovascular panel), a class 2 device. 33,838 medical device reports carry this product code, 0.1% of the MAUDE database, from February 1992 to August 2026.

2,117 reports arrived in the 12 months to August 2026, close to the 2,176 of 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 (57.4%), injury (38.9%) and death (2.8%). 30 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
V-18 Control Wire	554	47	0.7%	59.2%
Amplatz Super Stiff	520	50	4.7%	77.1%
Hi-Torque Balance Middleweight Universal Guide Wire	479	0	1.3%	51.1%
Starter guidewire	422	179	1.2%	73%
Amplatz Super Stiff Guidewire	385	0	3%	80.1%
Acs Hi-Torque Balance Middleweight Guide Wire	379	0	3.2%	57.9%
Arrow Ra Cath Set 22 Ga X 1-3/8	344	0	0%	96%
Radifocus Glidewire	330	25	2.1%	50.9%
V-14 Controlwire	325	0	0.3%	26.8%
Pt	322	13	4%	26.7%
V-14? Control Wire?	305	25	0.3%	52.8%
Acs Hi-Torque Balance Middleweight Guide Wire With Hydrocoat Hydrophilic Coating	304	0	1.3%	54.6%
Guide Wires	267	0	1.6%	55.1%
Runthrough Ns	259	0	1.9%	25.9%
Hi-Torque Pilot Guide Wire	256	0	4.3%	49.2%
Hi-Torque Command 18 Guide Wire	245	0	0%	69%
Pt2 Guide Wire	245	0	4.1%	24.5%
Hi-Torque Balance Middleweight	237	129	0%	78.1%
Rotablator Guide Wire	232	0	3.7%	55.7%
Fathom -16	216	19	0.5%	72.7%
Radifocus Guidewire M	212	3	1.4%	22.6%
Arrow Ra Cath Set 20 Ga X 1-3/4	209	0	0%	85.9%
Hi-Torque Balance Middleweight Elite Guide Wire	204	0	1%	77%
Ht Versaturn Guide Wire	201	0	0.5%	74.6%
Synchro-14 Straight 200-35cm	194	15	0%	86.6%
Hi-Torque Command	193	82	0%	80.3%
Confida Brecker Curve Guidewire	191	36	40.3%	5.2%
Preform Guidewire - Safari2	190	0	13.2%	60.5%
Enroute St Mod S Hy Us 95-014	183	13	1.6%	96.7%
Ht Command	168	0	0%	76.8%

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
Av-Temecula-Ct	3,207	9.5%
Abbott Vascular	3,120	9.2%
Asahi Intecc	1,937	5.7%
Boston Scientific	1,876	5.5%
Lake Region Medical	1,682	5%
Arrow International	1,639	4.8%
Terumo Ashitaka	1,498	4.4%
Cook	1,247	3.7%
Boston Scientific - Costa Rica Coyol	906	2.7%
Cordis	816	2.4%
Stryker Neurovascular-Utah-Salt Lake City	795	2.3%
Boston Scientific - Costa Rica Heredia	791	2.3%
Guidant Vascular Intervention	787	2.3%
Boston Scientific - Maple Grove	513	1.5%
Abbott Vascular-Cardiac Therapies	508	1.5%

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

Death2.8%932

Injury38.9%13,175

Malfunction57.4%19,418

Other0.5%176

Not given0.4%137

Who filed

Manufacturer report88.6%29,988

Voluntary report4.2%1,424

User facility report0%0

Distributor report2.2%747

Not given5%1,679

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

Device problems coded

Device problem (FDA code)	Reports	Share
Difficult to removethe device was hard to remove	5,197	15.4%
Breakthe device broke	3,843	11.4%
Material separation	3,507	10.4%
Detachment of device component	3,133	9.3%
Fracturea broken bone	2,654	7.8%
Peeled/delaminated	2,389	7.1%
Detachment of device or device componentpart of the device came off	1,947	5.8%
Entrapment of device	1,696	5%
Failure to advance	1,628	4.8%
Difficult to advance	1,556	4.6%
Stretched	1,299	3.8%
Tip breakage	1,280	3.8%
Device, or device fragments remain in patient	1,216	3.6%
Unraveled material	1,137	3.4%
Wire(s), breakage of	1,110	3.3%
Difficult to position	875	2.6%
Source, detachment from	803	2.4%
Improper or incorrect procedure or method	781	2.3%
Replace	760	2.2%
Material deformation	683	2%

Questions about wire, guide, catheter reports

What is product code DQX?

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

How many reports carry this code?

33,838 reports through August 2026, 2,117 of them in the latest 12 months.

Which brands appear most often?

V-18 Control Wire (554), Amplatz Super Stiff (520), Hi-Torque Balance Middleweight Universal Guide Wire (479), Starter guidewire (422) and Amplatz Super Stiff Guidewire (385). 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.