Devices › Wire, guide, catheter
Device brand name · Wire guide catheter
Guidewire: medical device reports filed with FDA
154 reports name it, 1995–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code DQX.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 5 a year
- 15
- reports, 12 months to August 2026
- 17 in the 12 months before
- 77.3%
- classified as malfunction
- 57.4% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
154 medical device reports received by FDA name the brand "Guidewire" (wire guide catheter); the manufacturer given most often on reports is C R Bard Basd -3006260740; received from January 1995 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
15 reports arrived in the 12 months to August 2026, down 12% from 17 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 (77.3%), injury (20.1%) and other (1.3%); across all wire, guide, catheter reports (product code DQX) death is recorded in 2.8% and malfunction in 57.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are component misassembled (27.3%), physical resistance/sticking (5.8%) and difficult to advance (4.5%). The patient problems coded most often are foreign body in patient, perforation of vessels and low blood pressure/ hypotension. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 33,838 reports carrying product code DQX. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Component misassembled | 42 | 27.3% | 0.1% |
| Physical resistance/sticking | 9 | 5.8% | 1.3% |
| Difficult to advance | 7 | 4.5% | 4.6% |
| Difficult to removethe device was hard to remove | 6 | 3.9% | 15.4% |
| Breakthe device broke | 4 | 2.6% | 11.4% |
| Material twisted/bent | 4 | 2.6% | 1.3% |
| Detachment of device or device componentpart of the device came off | 3 | 1.9% | 5.8% |
| Entrapment of device | 3 | 1.9% | 5% |
| Material integrity problema problem with the device material | 3 | 1.9% | 1.8% |
| Retraction problem | 2 | 1.3% | 0.2% |
| Activation, positioning or separation problem | 1 | 0.6% | 0.2% |
| Component or accessory incompatibility | 1 | 0.6% | 0% |
| Device misassembled during manufacturing /shipping | 1 | 0.6% | 0.1% |
| Device-device incompatibility | 1 | 0.6% | 0.1% |
| Difficult or delayed positioning | 1 | 0.6% | 0.2% |
| Difficult to insertthe device was hard to insert | 1 | 0.6% | 1.8% |
| Inadequacy of device shape and/or size | 1 | 0.6% | 0.1% |
| Malposition of device | 1 | 0.6% | 0.1% |
| Material split, cut or torn | 1 | 0.6% | 1.2% |
| Material too rigid or stiff | 1 | 0.6% | 0.1% |
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) | Reports | Share |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 5 | 3.2% |
| Perforation of vessels | 4 | 2.6% |
| Low blood pressure/ hypotension | 2 | 1.3% |
| Pericardial effusionfluid around the heart | 2 | 1.3% |
| Cardiac perforation | 1 | 0.6% |
| Cardiac tamponade | 1 | 0.6% |
| Device embedded in tissue or plaque | 1 | 0.6% |
| Failure of implant | 1 | 0.6% |
| Hemoptysis | 1 | 0.6% |
| Joint dislocationa dislocated joint | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Pleural effusionfluid around the lung | 1 | 0.6% |
| Vascular dissection | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Guidewire | Product code DQX | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 33,838 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 6 | 28 | 9 |
| Classified as injury | 20.1% | 38.9% | 36.2% |
| Classified as malfunction | 77.3% | 57.4% | 62.3% |
| Filed by the manufacturer | 63% | 88.6% | 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 DQX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| V-18 Control Wire | 554 | 47 | 0.7% |
| Amplatz Super Stiff | 658 | 50 | 4.7% |
| Hi-Torque Balance Middleweight Universal Guide Wire | 479 | 0 | 1.3% |
| Starter guidewire | 422 | 179 | 1.2% |
| Amplatz Super Stiff Guidewire | 403 | 0 | 3% |
| Acs Hi-Torque Balance Middleweight Guide Wire | 380 | 0 | 3.2% |
| Arrow Ra Cath Set 22 Ga X 1-3/8 | 346 | 0 | 0% |
| Radifocus Glidewire | 330 | 25 | 2.1% |
| V-14 Controlwire | 325 | 0 | 0.3% |
| Pt | 322 | 13 | 4% |
| V-14? Control Wire? | 305 | 25 | 0.3% |
| Acs Hi-Torque Balance Middleweight Guide Wire With Hydrocoat Hydrophilic Coating | 304 | 0 | 1.3% |
| Guide Wires | 374 | 0 | 1.6% |
| Runthrough Ns | 259 | 0 | 1.9% |
| Hi-Torque Pilot Guide Wire | 256 | 0 | 4.3% |
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 Guidewire reports
How many FDA reports name Guidewire?
154 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
malfunction (77.3%), injury (20.1%) and other (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
component misassembled (27.3%), physical resistance/sticking (5.8%), difficult to advance (4.5%), difficult to remove (3.9%) and break (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (63%), voluntary reports (29.2%) and distributor reports (1.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Guidewire 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.