Devices › Injector and syringe, angiographic
Device brand name · Ct injection system
Stellant Dual Ct Injector: medical device reports filed with FDA
236 reports name it, 2011–2026. Manufacturer given most often on reports: Bayer Medical Care. Product code DXT.
- 236
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 12
- reports, 12 months to August 2026
- 20 in the 12 months before
- 26.3%
- classified as malfunction
- 54% across the product code
- 8.1%
- classified as death, as reported
- 19 reports · not verified by FDA
236 medical device reports received by FDA name the brand "Stellant Dual Ct Injector" (ct injection system); the manufacturer given most often on reports is Bayer Medical Care; received from February 2011 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
12 reports arrived in the 12 months to August 2026, down 40% from 20 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 (62.7%), malfunction (26.3%) and death (8.1%); across all injector and syringe, angiographic reports (product code DXT) death is recorded in 4.4% and malfunction in 54%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (11.9%), insufficient device problem information (9.7%) and smoking (7.2%). The patient problems coded most often are air embolism, extravasation and no patient involvement. 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 3,323 reports carrying product code DXT. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 28 | 11.9% | 1.2% |
| Insufficient device problem information | 23 | 9.7% | 6% |
| Smoking | 17 | 7.2% | 0.7% |
| Air leak | 13 | 5.5% | 9.4% |
| Mechanical problema mechanical problem | 9 | 3.8% | 0.6% |
| Nonstandard device | 8 | 3.4% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.1% | 3.5% |
| Breakthe device broke | 4 | 1.7% | 5.5% |
| Improper or incorrect procedure or method | 4 | 1.7% | 2.8% |
| Material integrity problema problem with the device material | 4 | 1.7% | 0.6% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 1.7% | 0.3% |
| Device emits odor | 3 | 1.3% | 0.1% |
| Fire | 3 | 1.3% | 0.1% |
| Sparking | 3 | 1.3% | 0.1% |
| Thermal decomposition of device | 3 | 1.3% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.8% | 0.1% |
| Electrostatic discharge | 2 | 0.8% | 0% |
| Excess flow or over-infusion | 2 | 0.8% | 0.2% |
| Component falling | 1 | 0.4% | 3.2% |
| Defective devicethe device was defective | 1 | 0.4% | 0.6% |
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 |
|---|---|---|
| Air embolism | 71 | 30.1% |
| Extravasation | 43 | 18.2% |
| No patient involvement | 25 | 10.6% |
| Cardiac arrestthe heart stopped | 9 | 3.8% |
| Not applicable | 8 | 3.4% |
| Deaththe patient died; cause not stated by this term | 7 | 3% |
| Painpain, site not specified | 7 | 3% |
| Infiltration into tissue | 6 | 2.5% |
| Respiratory failurethe lungs could not supply enough oxygen | 6 | 2.5% |
| Swellingswelling | 6 | 2.5% |
| Dyspneashortness of breath | 3 | 1.3% |
| Edemaswelling from fluid | 3 | 1.3% |
| Hypersensitivity/allergic reaction | 3 | 1.3% |
| Bone fracture(s) | 2 | 0.8% |
| Electric shockan electric shock | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Stellant Dual Ct Injector | Product code DXT | All MAUDE reports |
|---|---|---|---|
| Reports | 236 | 3,323 | 26,136,888 |
| Share of that pool | — | 7.1% | 0% |
| Classified as death, per 1,000 reports | 81 | 44 | 9 |
| Classified as injury | 62.7% | 32% | 36.2% |
| Classified as malfunction | 26.3% | 54% | 62.3% |
| Filed by the manufacturer | 100% | 81.7% | 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 DXT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Acist | 348 | 14 | 10.6% |
| Medrad Ct Injector | 174 | 0 | 2.9% |
| Boston Scientific | 580 | 5 | 3.3% |
| BD Syringe | 480 | 117 | 0.4% |
| Deroyal | 587 | 14 | 0.7% |
| Navilyst Medical | 252 | 0 | 0.4% |
| Bd | 191 | 0 | 1% |
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 Stellant Dual Ct Injector reports
How many FDA reports name Stellant Dual Ct Injector?
236 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.
What kinds of events are reported?
injury (62.7%), malfunction (26.3%) and death (8.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (11.9%), insufficient device problem information (9.7%), smoking (7.2%), air leak (5.5%) and mechanical problem (3.8%). 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 Stellant Dual Ct Injector 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.