Devices › Catheter, coronary, atherectomy
Device brand name · Catheter coronary atherectomy
AngioJet Ultra System Console: medical device reports filed with FDA
162 reports name it, 2015–2026. Manufacturer given most often on reports: Boston Scientific. Product code MCX.
- 162
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 11
- reports, 12 months to August 2026
- 5 in the 12 months before
- 95.1%
- classified as malfunction
- 55.3% across the product code
- 1.2%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 162 reports that name the brand "AngioJet Ultra System Console" (catheter coronary atherectomy), received between July 2015 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
11 reports arrived in the 12 months to August 2026, up 120% from 5 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 (95.1%), injury (3.7%) and death (1.2%); across all catheter, coronary, atherectomy reports (product code MCX) death is recorded in 7.4% and malfunction in 55.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (21.6%), aspiration issue (19.8%) and display or visual feedback problem (19.1%). The patient problems coded most often are no patient involvement, death and renal failure. 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 11,889 reports carrying product code MCX. 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 displays incorrect message | 35 | 21.6% | 0.4% |
| Aspiration issue | 32 | 19.8% | 0.4% |
| Display or visual feedback problem | 31 | 19.1% | 0.9% |
| Sticking | 20 | 12.3% | 1% |
| Defective devicethe device was defective | 11 | 6.8% | 0.7% |
| No display/image | 6 | 3.7% | 2.2% |
| Device damaged by another device | 4 | 2.5% | 5.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 2.5% | 2.4% |
| Difficult to open or close | 4 | 2.5% | 0.1% |
| Failure to prime | 4 | 2.5% | 0.1% |
| Mechanical problema mechanical problem | 4 | 2.5% | 1.5% |
| Physical resistance/sticking | 4 | 2.5% | 0.6% |
| Suction problem | 3 | 1.9% | 0.1% |
| Improper flow or infusion | 2 | 1.2% | 0.1% |
| Power problem | 2 | 1.2% | 0% |
| Unexpected shutdown | 2 | 1.2% | 0.3% |
| Breakthe device broke | 1 | 0.6% | 2.3% |
| Connection problema connection problem | 1 | 0.6% | 0.1% |
| Defective component | 1 | 0.6% | 0.2% |
| Device remains activated | 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 |
|---|---|---|
| No patient involvement | 24 | 14.8% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Renal failurekidney failure | 2 | 1.2% |
| Bradycardiaslow heart rate | 1 | 0.6% |
| Embolism | 1 | 0.6% |
| Hematuria | 1 | 0.6% |
| Injurya physical injury | 1 | 0.6% |
| Reocclusion | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AngioJet Ultra System Console | Product code MCX | All MAUDE reports |
|---|---|---|---|
| Reports | 162 | 11,889 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 12 | 74 | 9 |
| Classified as injury | 3.7% | 36.9% | 36.2% |
| Classified as malfunction | 95.1% | 55.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 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 MCX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| RotaLink? Plus | 1,957 | 42 | 4.4% |
| Rotablator Rotational Atherectomy System | 1,917 | 88 | 7% |
| Rotapro | 1,565 | 313 | 4.7% |
| Diamondback 360 Coronary Orbital Atherectomy System | 1,512 | 0 | 15.7% |
| RotaWire and wireClip Torquer | 1,462 | 84 | 3.8% |
| RotaLink Burr | 627 | 39 | 8.1% |
| Diamondback Coronary | 492 | 222 | 15.9% |
| ROTAWIRE Drive | 369 | 85 | 3.5% |
| Rotalink Catheter | 154 | 0 | 13% |
| Rotablator Guide Wire | 352 | 0 | 3.7% |
| Diamondback 360 Peripheral Orbital Atherectomy System | 676 | 0 | 0.9% |
| AngioJet SOLENT omni | 671 | 26 | 1.3% |
| Diamondback 360 Orbital Atherectomy System | 241 | 0 | 3.3% |
| Selox JT 53 | 150 | 5 | 0% |
| Synergy | 14,271 | 84 | 3.5% |
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 AngioJet Ultra System Console reports
How many FDA reports name AngioJet Ultra System Console?
162 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
malfunction (95.1%), injury (3.7%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (21.6%), aspiration issue (19.8%), display or visual feedback problem (19.1%), sticking (12.3%) and defective device (6.8%). 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 AngioJet Ultra System Console 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.