Devices › Catheter, ultrasound, intravascular
Device brand name · Catheter ultrasound intravascular
Soundstar: medical device reports filed with FDA
169 reports name it, 2017–2026. Manufacturer given most often on reports: Biosense Webster. Product code OBJ.
- 169
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 29
- reports, 12 months to August 2026
- 43 in the 12 months before
- 82.2%
- classified as malfunction
- 85% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
169 medical device reports received by FDA name the brand "Soundstar" (catheter ultrasound intravascular); the manufacturer given most often on reports is Biosense Webster; received from June 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
29 reports arrived in the 12 months to August 2026, down 33% from 43 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 (82.2%) and injury (17.2%); across all catheter, ultrasound, intravascular reports (product code OBJ) death is recorded in 1% and malfunction in 85%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient device interaction problem (13%), contamination /decontamination problem (6.5%) and device sensing problem (4.7%). The patient problems coded most often are cardiac tamponade, cardiac perforation and arrhythmia. 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 7,935 reports carrying product code OBJ. 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 |
|---|---|---|---|
| Patient device interaction problem | 22 | 13% | 1.6% |
| Contamination /decontamination problem | 11 | 6.5% | 1.1% |
| Device sensing problem | 8 | 4.7% | 0.3% |
| Display or visual feedback problem | 8 | 4.7% | 0.6% |
| Mechanical jam | 8 | 4.7% | 0.3% |
| Connection problema connection problem | 7 | 4.1% | 1.1% |
| Tear, rip or hole in device packaging | 6 | 3.6% | 0.2% |
| No display/image | 5 | 3% | 9.5% |
| Protective measures problem | 5 | 3% | 0.1% |
| Device displays incorrect message | 4 | 2.4% | 1.3% |
| Manufacturing, packaging or shipping problem | 4 | 2.4% | 0.1% |
| Activation, positioning or separation problem | 3 | 1.8% | 0.2% |
| Defective devicethe device was defective | 3 | 1.8% | 0.3% |
| Device-device incompatibility | 3 | 1.8% | 0.4% |
| Failure to sense | 3 | 1.8% | 0.1% |
| Therapeutic or diagnostic output failure | 3 | 1.8% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 2 | 1.2% | 0.3% |
| Insufficient device problem information | 2 | 1.2% | 0.5% |
| Material protrusion/extrusion | 2 | 1.2% | 0.1% |
| Output problem | 2 | 1.2% | 0.4% |
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 |
|---|---|---|
| Cardiac tamponade | 10 | 5.9% |
| Cardiac perforation | 6 | 3.6% |
| Arrhythmia | 1 | 0.6% |
| Asystole | 1 | 0.6% |
| Failure of implant | 1 | 0.6% |
| Fistula | 1 | 0.6% |
| Heart block | 1 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
| Ischemic heart disease | 1 | 0.6% |
| Myocardial infarctionheart attack | 1 | 0.6% |
| Thrombosis/thrombus | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Soundstar | Product code OBJ | All MAUDE reports |
|---|---|---|---|
| Reports | 169 | 7,935 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 10 | 9 |
| Classified as injury | 17.2% | 13.7% | 36.2% |
| Classified as malfunction | 82.2% | 85% | 62.3% |
| Filed by the manufacturer | 33.7% | 92.2% | 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 OBJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| OptiCross | 1,960 | 136 | 0.9% |
| OptiCross HD | 1,717 | 617 | 0.6% |
| iLab Ultrasound Imaging System | 1,075 | 85 | 0.2% |
| ViewFlex Xtra ICE Catheter | 418 | 66 | 1.2% |
| OptiCross? 6 HD | 409 | 144 | 2% |
| OptiCross 18 | 352 | 31 | 0% |
| Acuson | 691 | 0 | 0.4% |
| Acist | 348 | 14 | 10.6% |
| Decanav Electrophysiology Catheter | 153 | 4 | 3.3% |
| Dexcom G6 Continuous Glucose Monitoring System | 1,339,562 | 61,710 | 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 Soundstar reports
How many FDA reports name Soundstar?
169 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 29 in the latest 12 months.
What kinds of events are reported?
malfunction (82.2%) and injury (17.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (13%), contamination /decontamination problem (6.5%), device sensing problem (4.7%), display or visual feedback problem (4.7%) and mechanical jam (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (33.7%) and distributor reports (4.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Soundstar 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.