Devices › Catheter, intravascular, diagnostic
Device brand name · Catheter intravascular diagnostic
Merit Custom Kit: medical device reports filed with FDA
1,590 reports name it, 2006–2026. Manufacturer given most often on reports: Merit Medical Systems. Product code DQO.
- 1,590
- device reports naming the brand
- 0% of all MAUDE reports · about 80 a year
- 13
- reports, 12 months to August 2026
- 49 in the 12 months before
- 96.7%
- classified as malfunction
- 56% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 1,590 reports that name the brand "Merit Custom Kit" (catheter intravascular diagnostic), received between July 2006 and August 2026; the manufacturer given most often on reports is Merit Medical Systems. Spellings of one product vary from report to report.
13 reports arrived in the 12 months to August 2026, down 73% from 49 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 (96.7%), injury (3.2%) and death (0.1%); across all catheter, intravascular, diagnostic reports (product code DQO) death is recorded in 2.2% and malfunction in 56%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with chemical or other material (28.2%), break (15.2%) and tear, rip or hole in device packaging (9.6%). The patient problems coded most often are no patient involvement, air embolism 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 20,198 reports carrying product code DQO. 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 |
|---|---|---|---|
| Device contamination with chemical or other material | 448 | 28.2% | 2.8% |
| Breakthe device broke | 241 | 15.2% | 13.8% |
| Tear, rip or hole in device packaging | 152 | 9.6% | 0.7% |
| Unsealed device packaging | 132 | 8.3% | 0.5% |
| Delivered as unsterile product | 104 | 6.5% | 0.8% |
| Air leak | 92 | 5.8% | 1% |
| Packaging problem | 54 | 3.4% | 0.3% |
| Contamination of device ingredient or reagent | 47 | 3% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 40 | 2.5% | 0.5% |
| Fluid/blood leak | 39 | 2.5% | 2.5% |
| Leak/splashthe device leaked | 37 | 2.3% | 6.2% |
| Device packaging compromised | 33 | 2.1% | 0.3% |
| Detachment of device component | 30 | 1.9% | 3.8% |
| Contamination | 27 | 1.7% | 0.3% |
| Manufacturing, packaging or shipping problem | 21 | 1.3% | 0% |
| Defective devicethe device was defective | 20 | 1.3% | 0.3% |
| Problem with sterilization | 20 | 1.3% | 0% |
| Crackthe device cracked | 19 | 1.2% | 3.3% |
| Device damaged prior to usethe device was damaged before use | 18 | 1.1% | 0.3% |
| Material separation | 18 | 1.1% | 9.8% |
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 |
|---|---|---|
| No patient involvement | 387 | 24.3% |
| Air embolism | 17 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 5 | 0.3% |
| Pneumothoraxa collapsed lung | 5 | 0.3% |
| Embolus | 2 | 0.1% |
| Ischemia | 2 | 0.1% |
| Not applicable | 2 | 0.1% |
| St segment elevation | 2 | 0.1% |
| Arrhythmia | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Chemical exposure | 1 | 0.1% |
| Device embedded in tissue or plaque | 1 | 0.1% |
| Exposure to body fluids | 1 | 0.1% |
| Hemorrhage/blood loss/bleeding | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Merit Custom Kit | Product code DQO | All MAUDE reports |
|---|---|---|---|
| Reports | 1,590 | 20,198 | 26,136,888 |
| Share of that pool | — | 7.9% | 0% |
| Classified as death, per 1,000 reports | 1 | 22 | 9 |
| Classified as injury | 3.2% | 37.6% | 36.2% |
| Classified as malfunction | 96.7% | 56% | 62.3% |
| Filed by the manufacturer | 100% | 82.1% | 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 DQO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultrasonic Imaging Catheter - Coronary | 569 | 0 | 0% |
| Trapease Pvcf Fem/Jug 55cm Csi | 983 | 0 | 3.7% |
| 466p306x | 717 | 0 | 1.8% |
| Renegade | 301 | 0 | 0.3% |
| Infiniti | 267 | 141 | 0% |
| Tempo | 721 | 155 | 0.7% |
| Impress Braided Catheter | 215 | 0 | 0% |
| Impress | 200 | 25 | 1% |
| Impress Peripheral Catheter | 186 | 0 | 0% |
| Dragonfly OpStar | 187 | 88 | 0.5% |
| V-Cath | 175 | 0 | 1.7% |
| Arrow | 830 | 65 | 3.4% |
| Bard | 1,124 | 2 | 1.8% |
| Trapease Filter | 165 | 0 | 13.9% |
| Guide Wires | 374 | 0 | 1.6% |
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 Merit Custom Kit reports
How many FDA reports name Merit Custom Kit?
1,590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
malfunction (96.7%), injury (3.2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with chemical or other material (28.2%), break (15.2%), tear, rip or hole in device packaging (9.6%), unsealed device packaging (8.3%) and delivered as unsterile product (6.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Merit Custom Kit 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.