Devices › Wire, guide, catheter
Device brand name · Guidewire
Radifocus Glidewire: medical device reports filed with FDA
330 reports name it, 1998–2026. Manufacturer given most often on reports: Terumo Ashitaka. Product code DQX.
- 330
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 25
- reports, 12 months to August 2026
- 3 in the 12 months before
- 50.9%
- classified as malfunction
- 57.4% across the product code
- 2.1%
- classified as death, as reported
- 7 reports · not verified by FDA
330 medical device reports received by FDA name the brand "Radifocus Glidewire" (guidewire); the manufacturer given most often on reports is Terumo Ashitaka; received from June 1998 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
25 reports arrived in the 12 months to August 2026, up 733% from 3 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 (50.9%), injury (45.5%) and death (2.1%); 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 break (30.3%), detachment of device component (29.1%) and tears, rips, holes in device, device material (19.4%). The patient problems coded most often are foreign body, removal of, surgery, prolonged and foreign body in patient. 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 |
|---|---|---|---|
| Breakthe device broke | 100 | 30.3% | 11.4% |
| Detachment of device component | 96 | 29.1% | 9.3% |
| Tears, rips, holes in device, device material | 64 | 19.4% | 0.5% |
| Steering wire problem | 37 | 11.2% | 0.2% |
| Material separation | 31 | 9.4% | 10.4% |
| Peeled/delaminated | 18 | 5.5% | 7.1% |
| Device, or device fragments remain in patient | 14 | 4.2% | 3.6% |
| Replace | 14 | 4.2% | 2.2% |
| Difficult to removethe device was hard to remove | 10 | 3% | 15.4% |
| Fracturea broken bone | 7 | 2.1% | 7.8% |
| Difficult to insertthe device was hard to insert | 6 | 1.8% | 1.8% |
| Improper or incorrect procedure or method | 6 | 1.8% | 2.3% |
| Material fragmentation | 6 | 1.8% | 0.9% |
| Insulation, detached | 5 | 1.5% | 0.1% |
| Sticking | 5 | 1.5% | 1.9% |
| Device or device fragments location unknown | 4 | 1.2% | 0.2% |
| Device, removal of (non-implant) | 4 | 1.2% | 1.4% |
| Failure to advance | 4 | 1.2% | 4.8% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 1.2% | 0.9% |
| Component(s), broken | 3 | 0.9% | 0.2% |
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, removal of | 40 | 12.1% |
| Surgery, prolonged | 35 | 10.6% |
| Foreign body in patientpart of a device left in the patient | 32 | 9.7% |
| Device embedded in tissue or plaque | 25 | 7.6% |
| Nonresorbable materials, unretrieved in body | 23 | 7% |
| Surgical procedure, additional | 10 | 3% |
| Surgical procedure | 9 | 2.7% |
| Perforation | 5 | 1.5% |
| Therapy/non-surgical treatment, additional | 5 | 1.5% |
| Perforation of vessels | 4 | 1.2% |
| Low blood pressure/ hypotension | 3 | 0.9% |
| No patient involvement | 3 | 0.9% |
| Surgical procedure aborted/stopped | 3 | 0.9% |
| Deaththe patient died; cause not stated by this term | 2 | 0.6% |
| Embolus | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Radifocus Glidewire | Product code DQX | All MAUDE reports |
|---|---|---|---|
| Reports | 330 | 33,838 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 21 | 28 | 9 |
| Classified as injury | 45.5% | 38.9% | 36.2% |
| Classified as malfunction | 50.9% | 57.4% | 62.3% |
| Filed by the manufacturer | 90.6% | 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% |
| 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% |
| Hi-Torque Command 18 Guide Wire | 245 | 0 | 0% |
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 Radifocus Glidewire reports
How many FDA reports name Radifocus Glidewire?
330 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 25 in the latest 12 months.
What kinds of events are reported?
malfunction (50.9%), injury (45.5%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (30.3%), detachment of device component (29.1%), tears, rips, holes in device, device material (19.4%), steering wire problem (11.2%) and material separation (9.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (90.6%), distributor reports (4.5%) and voluntary reports (1.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Radifocus Glidewire 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.