Catheter, ultrasound, intravascular: medical device reports filed with FDA

7,935 reports carry this product code, 2004–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

7,935
reports with this product code: 0% of all MAUDE reports; 1,202
reports, 12 months to August 2026: 725 in the 12 months before; 85%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

Product code OBJ is FDA's classification for "Catheter, ultrasound, intravascular" (cardiovascular panel), a class 2 device. 7,935 medical device reports carry this product code, 0% of the MAUDE database, from June 2004 to August 2026.

1,202 reports arrived in the 12 months to August 2026, up 66% from 725 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 (85%), injury (13.7%) and death (1%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
OptiCross	1,948	136	0.9%	87.2%
OptiCross HD	1,700	617	0.6%	87.7%
iLab Ultrasound Imaging System	913	85	0.2%	98.5%
ViewFlex Xtra ICE Catheter	396	66	1.2%	86.8%
OptiCross? 6 HD	360	144	2%	86.6%
OptiCross 18	312	31	0%	88.9%
Soundstar	168	29	0%	82.2%
Acuson	85	0	0.4%	92.9%
Acist	13	14	10.6%	14.9%
Decanav Electrophysiology Catheter	1	4	3.3%	32.7%
Dexcom G6 Continuous Glucose Monitoring System	1	61,710	0%	99.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Boston Scientific - Fremont Ce	829	10.4%
Volcano	573	7.2%
Boston Scientific - Fremont Sud	526	6.6%
Biosense Webster	493	6.2%
Boston Scientific - Costa Rica Coyol	490	6.2%
Siemens Medical Solutions USA	336	4.2%
St Jude Medical	207	2.6%
Dexcom	52	0.7%
Biosense Webster Irwindale	48	0.6%
St Jude Medical Costa Rica Ltda	18	0.2%
Philips Ultrasound	3	0%
Abbott Laboratories	2	0%
Abbott Diabetes Care	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1%77

Injury13.7%1,089

Malfunction85%6,748

Other0.2%16

Not given0.1%5

Who filed

Manufacturer report92.2%7,320

Voluntary report1.2%92

User facility report0%0

Distributor report1.2%92

Not given5.4%431

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Retraction problem	1,163	14.7%
Entrapment of device	1,056	13.3%
Poor quality image	958	12.1%
No display/image	753	9.5%
Detachment of device or device componentpart of the device came off	674	8.5%
Air/gas in device	432	5.4%
Material deformation	409	5.2%
Fracturea broken bone	373	4.7%
Material separation	357	4.5%
Material twisted/bent	351	4.4%
Material integrity problema problem with the device material	303	3.8%
Failure to advance	269	3.4%
Nonstandard device	241	3%
Difficult to flush	217	2.7%
Physical resistance/sticking	168	2.1%
Unable to obtain readings	157	2%
Patient device interaction problem	124	1.6%
Detachment of device component	108	1.4%
Breakthe device broke	107	1.3%
Device displays incorrect message	103	1.3%

Questions about catheter, ultrasound, intravascular reports

What is product code OBJ?

FDA's classification code for "Catheter, ultrasound, intravascular", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,935 reports through August 2026, 1,202 of them in the latest 12 months.

Which brands appear most often?

OptiCross (1,948), OptiCross HD (1,700), iLab Ultrasound Imaging System (913), ViewFlex Xtra ICE Catheter (396) and OptiCross? 6 HD (360). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.