Devices › Catheter, ultrasound, intravascular
Device brand name · Catheter ultrasound intravascular
ViewFlex Xtra ICE Catheter: medical device reports filed with FDA
418 reports name it, 2017–2026. Manufacturer given most often on reports: St Jude Medical. Product code OBJ.
- 418
- device reports naming the brand
- 0% of all MAUDE reports · about 45 a year
- 66
- reports, 12 months to August 2026
- 75 in the 12 months before
- 86.8%
- classified as malfunction
- 85% across the product code
- 1.2%
- classified as death, as reported
- 5 reports · not verified by FDA
418 medical device reports received by FDA name the brand "ViewFlex Xtra ICE Catheter" (catheter ultrasound intravascular); the manufacturer given most often on reports is St Jude Medical; received from March 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
66 reports arrived in the 12 months to August 2026, down 12% from 75 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 (86.8%), injury (12%) and death (1.2%); 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 fracture (77.3%), material twisted/bent (4.3%) and difficult to insert (2.9%). The patient problems coded most often are cardiac perforation, perforation and vascular dissection. 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 |
|---|---|---|---|
| Fracturea broken bone | 323 | 77.3% | 4.7% |
| Material twisted/bent | 18 | 4.3% | 4.4% |
| Difficult to insertthe device was hard to insert | 12 | 2.9% | 0.2% |
| Breakthe device broke | 10 | 2.4% | 1.3% |
| Display or visual feedback problem | 10 | 2.4% | 0.6% |
| Material separation | 10 | 2.4% | 4.5% |
| Activation, positioning or separation problem | 8 | 1.9% | 0.2% |
| Communication or transmission problemthe device could not communicate or transmit | 8 | 1.9% | 0.3% |
| Material frayed | 4 | 1% | 0.1% |
| Entrapment of device | 3 | 0.7% | 13.3% |
| Improper or incorrect procedure or method | 3 | 0.7% | 0.1% |
| Contamination /decontamination problem | 1 | 0.2% | 1.1% |
| Difficult to removethe device was hard to remove | 1 | 0.2% | 1.3% |
| Insufficient device problem information | 1 | 0.2% | 0.5% |
| Material too rigid or stiff | 1 | 0.2% | 0% |
| Mechanical jam | 1 | 0.2% | 0.3% |
| Output problem | 1 | 0.2% | 0.4% |
| Patient device interaction problem | 1 | 0.2% | 1.6% |
| Signal artifact/noise | 1 | 0.2% | 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 |
|---|---|---|
| Cardiac perforation | 23 | 5.5% |
| Perforation | 4 | 1% |
| Vascular dissection | 4 | 1% |
| Deaththe patient died; cause not stated by this term | 3 | 0.7% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.5% |
| Great vessel perforation | 2 | 0.5% |
| Aneurysm | 1 | 0.2% |
| Arrhythmia | 1 | 0.2% |
| Heart block | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Hemothorax | 1 | 0.2% |
| Internal organ perforation | 1 | 0.2% |
| Low blood pressure/ hypotension | 1 | 0.2% |
| Pericardial effusionfluid around the heart | 1 | 0.2% |
| Respiratory failurethe lungs could not supply enough oxygen | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ViewFlex Xtra ICE Catheter | Product code OBJ | All MAUDE reports |
|---|---|---|---|
| Reports | 418 | 7,935 | 26,136,888 |
| Share of that pool | — | 5.3% | 0% |
| Classified as death, per 1,000 reports | 12 | 10 | 9 |
| Classified as injury | 12% | 13.7% | 36.2% |
| Classified as malfunction | 86.8% | 85% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| OptiCross? 6 HD | 409 | 144 | 2% |
| OptiCross 18 | 352 | 31 | 0% |
| Soundstar | 169 | 29 | 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 ViewFlex Xtra ICE Catheter reports
How many FDA reports name ViewFlex Xtra ICE Catheter?
418 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 66 in the latest 12 months.
What kinds of events are reported?
malfunction (86.8%), injury (12%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (77.3%), material twisted/bent (4.3%), difficult to insert (2.9%), break (2.4%) and display or visual feedback problem (2.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ViewFlex Xtra ICE Catheter 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.